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Healthcare Medical Director – Spine Surgery (Orthopedic or Neurosurgery) – Evicore - Remote

Medical director applies clinical expertise in spine surgery to guide clinical decision-making and oversight at a healthcare organization.

Lead Remote Posted about 10 hours ago Himalayas
What this role involves
Do you crave an intellectually stimulating role that lets you apply your clinical expertise while continuing to grow and make an impact?
Read the full description
Healthcare In-Home Health - Nurse Practitioner or Physician Assistant (Full Time)

Nurse Practitioner or Physician Assistant provides in-home clinical care and medical services to patients remotely from Minnesota.

Senior Remote Posted about 10 hours ago Himalayas
What this role involves
Job Title: In-Home Health - Nurse Practitioner or Physician Assistant (Full Time) - Job Location: Work at Home, Minnesota, United States Job Location Type: Remote Job Contract Type: Full time Job Seniority Level: We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience.
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Healthcare Clinical Scientist Director - Late Development Oncology

Leads clinical development strategy and execution for late-stage oncology programs, overseeing trial design, regulatory compliance, and patient outcomes.

Lead Posted about 10 hours ago Himalayas
What this role involves
Career CategoryClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are.
Read the full description
Healthcare Regional Medical Scientific Director (aka Medical Science Liaison) Immunology -

Regional Medical Scientific Director provides medical expertise and scientific support to healthcare professionals in immunology and inflammatory bowel disease therapeutics.

Senior Posted about 10 hours ago Himalayas
What this role involves
Job DescriptionWe are seeking a Growth and Improvement minded Regional Medical Scientific Director (aka Medical Science Liaison, MSL) in Inflammatory Bowel Disease Immunology that can help drive our Strategic Operating Priorities.
Read the full description
Healthcare Clinical Pharmacist – Cardiology / Value-Based Care

Clinical pharmacist optimizes cardiac medication therapy and titration in collaboration with nurses and cardiology providers in a value-based care setting.

Mid Remote Posted 1 day ago Himalayas
What this role involves
Clinical Pharmacist – Cardiology / Value-Based Care A remote clinical pharmacist role optimizing cardiac medication therapy and titration in partnership with nurses and cardiology providers.
Read the full description
Healthcare Staff Physician, 24/7 Care (1099)

Provides 24/7 virtual medical care to patients as a staff-level physician on a contract basis.

Senior Remote Posted 1 day ago Himalayas
What this role involves
Join the team leading the next evolution of virtual care.
Read the full description
Healthcare Clinical Interviewer – Digital Mental Health Research (Doctoral-Level)

Conducts clinical interviews and rates patient outcomes for digital mental health research studies as a doctoral-level mental health specialist.

Senior Remote Posted 1 day ago Himalayas
What this role involves
This is a remote position. Clinical Interviewer/Rater – Digital Mental Health Research (Doctoral-Level)Location:US RemoteJob Type:Full-Time, PermanentCompensation:$100,000–$150,000 About the RoleDeliberate is looking for a doctoral-level mental health specialist to join our clinical research team.
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Healthcare Remote SLP (Speech Language Pathologist) Minnesota K-12 Schools

Speech Language Pathologist provides assessment and treatment services to K-12 students in Minnesota schools remotely.

Mid Remote Posted 1 day ago Himalayas
What this role involves
$315-$415 daily rate; rates are negotiable and subject to change.
Read the full description
Healthcare Director/Head, Pharmacovigilance at Orca

Leads pharmacovigilance safety function at biotech company, overseeing risk management, regulatory compliance, and safety governance for cell therapy products.

Lead Posted 2 days ago RemoteFirstJobs Product
What this role involves

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

Key Responsibilities

  • Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
  • Responsible for providing safety-related content for all clinical and regulatory documents.
  • Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
  • Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
  • Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
  • Represent product safety in the cross-functional team environment.
  • Lead safety governance activities in collaboration with medical monitors and leadership.
  • Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
  • Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

Qualifications

  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
  • 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
  • Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
  • Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
  • Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
  • Experience with clinical development, risk/benefit analysis, and safety assessment.
  • Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
  • Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
  • Hands-on mentality, ability to operate in a small biotech environment.
  • Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
  • Expertise in analyzing safety data from clinical and safety databases.
  • Experience in MedDRA coding and search strategies.
  • Excellent independent judgment based on knowledge and expertise.
  • Strong personal time management and project management skills.

$200,000 - $245,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Read the full description
Healthcare Medical Director - Critical Care at Ceribell

Medical Director provides clinical leadership and medical expertise to guide product strategy, engage physicians and hospital customers, and drive evidence generation for a neurological diagnostic technology company.

Lead Posted 2 days ago RemoteFirstJobs Product
What this role involves

About Ceribell

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN’s across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!

The Medical Director will be a key member of the management team, providing medical oversight, expertise, and leadership to support Ceribell’s strategy to expand clinical indications, develop new products, and implement clinical trials to continue to build evidence to support market adoption. The Medical Director will be a visible advocate for driving education and awareness on how neurological patients in the ICU and the floor are monitored and diagnosed, helping healthcare providers monitor and reduce time from ordering an EEG to set-up from an average of 4 hours to under 10 minutes. They will be an important spokesperson, including providing guidance on neuro-critical health-related matters with key opinion leaders at scientific conferences and advisory boards defining global standards of care for patients. S/he will have the credibility, experience, and relationships to drive initiatives and results.

What You Will Do

Strategy

  • Lead medical strategy and planning
  • Support clinical, marketing, and product strategy

Execution

  • Peer-to-peer engagement through sales (~70% time)
    • Working with sales to directly engage customers from pre-PO sales process, through hospital executive engagements, to workflow discussions
    • Educating the sales team on how to better engage customers (1-on-1 and directly working with sales trainer and sales leadership)
    • Developing other physician advocates for Ceribell so that these advocates can engage and present our products to more physicians
  • Peer-to-peer engagement through marketing (10%)
    • Support marketing in engaging different societies
    • Support advisory board
    • Give talks and webinars representing Ceribell
  • Evidence generation - support evidence generation and publications (10%)
    • Partner with clinical and marketing teams on post-market evidence:
      • Publication strategy and execution
      • Retrospective study strategy, design, and execution
      • Investigator-initiated study management and support
    • Identify and develop KOL and physician relationships:
      • To select appropriate partners for sponsored clinical trials and studies
      • To develop a network or fellows or residents who can assist with research and writing for Ceribell
    • Regulatory trials – support clinical/reg/R&D/Product team to design trials for data collection or approval by providing the medical expertise
    • Keep the organization updated with the latest literature
      • Identify key evidence or medical opportunities for the company
  • Provide medical expertise for cross-functional teams (10%)
    • To Product and R&D teams on future product development
    • To Regulatory and Reimbursement teams by interfacing with FDA and payers

What You Bring

  • MD, DO or MD/PhD degree required
  • An experienced Neurologist or Intensivist with at least 10 years of experience in industry or as an attending physician. The Company is open to having a full-time Neurologist or Intensivist with direct experience in industry as or alternatively, an attending Neurologist or Intensivist who can spend 50% of his/her time with Ceribell and 50% with their practice.
  • Critical care experience required
  • Experience with the Ceribell platform
  • Experience and strong knowledge of neurological assessment and acute care workflow – highly desired.
  • Analytical and strategic thinking capabilities along with good judgment and decision-making skills balanced with high degree of EQ and well-balanced ego.
  • A dedication to integrity, transparency and honesty is a must; an informal, direct personal style and a flexible approach are highly desirable attributes.
  • Data driven mindset with the capability to envision the application of new technologies in novel ways to solve complex patient needs.
  • A commercially oriented mindset is important. S/he should have a strong understanding of the product commercialization pathway and be able to add value to general business strategy.
  • Expertise in presenting breakthrough products and new technologies to physicians.
  • Highly developed understanding of the external marketplace and medical literature to serve as a valuable key member of the executive team with the ability to bring medical and/or clinical knowledge to the analysis of the Company’s future commercial opportunities.
  • Excellent written, verbal communication, influence/leadership, and presentation skills to various audiences, particularly neurologists and intensivists as well as the ICU and other hospital administrators.
  • Ability to make reasonable tradeoffs and manage multiple priorities in a fast-paced, data driven entrepreneurial environment.
  • Creative and critical intellect with a ‘what if’ openness to new ideas and “thinks large”. Generates ideas/opportunities and turns them into successful results. Flexible about implementation while being inflexible about the quality and timeliness of results.
  • A results-oriented executive who conveys a sense of urgency and drives for closure. Able to execute and prioritize multiple, competing tasks and demands. Recognizes and executes critical details.
  • Effective collaborative interpersonal skills: persuasive, generates enthusiasm, credible at all levels of the organization.
  • Comfortable and productive with rapidly changing organizational needs and adept at managing in a start-up resource environment.
  • Assist in formulating a process that adds a business and market component to prioritizing research projects.
  • Ability to interface effectively with all levels and functions within the organization, as well as the Company’s Board of Directors.
  • Experience as a respected senior clinical/medical leader with an excellent working relationship with the FDA including a successful history of effective collaboration through clinical studies, market release and post- marketing activities.
  • Significant experience in relating to marketing and business issues with a focus on clinical and medical support of commercial assets.
  • Broad contacts in academic medical centers, major practice centers, and the medical device industry
  • Location: Remote (US-Based)
  • Travel required: Up to 40% travel required (typically 2 days per week)

This job description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.

Compensation Range

$300,000—$309,000 USD

A candidate’s final salary offer will be based on their skills, education, work location and experience, and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribell’s corporate compensation plan. Note, the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.

In addition to your base compensation, Ceribell offers eligible employees the following:

  • Performance-based incentive compensation (varies by role)
  • Equity opportunities
  • 100% Employer paid Health Benefits for Employees
  • 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
  • 100% paid Life and Long-Term Disability Insurance
  • 401(k) with a generous company match
  • Employee Stock Purchase Plan (ESPP) with a discount
  • Monthly cell phone stipend
  • Flexible paid time off
  • 13 Paid Holidays + 3 Company Wellness Days
  • Excellent parental leave policy
  • Fantastic culture with tremendous career advancement opportunities
  • Joining a mission-minded organization!

Application Deadline: Ongoing

Other Job Details Ceribell reports transfers of value to health care providers (HCPs) as required by federal and state transparency laws. These laws and implementing regulations require Ceribell to provide government agencies with HCPs’ names, addresses and the type of payments or other value received, generally for public disclosure. If you are an HCP and we pay or reimburse your recruiting expenses as a result of interviewing with Ceribell, your name, address and the amount of payments made may be reported to the government.

Equal Opportunity Employer Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status or any other characteristic protected by law. Ceribell complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Ceribell is an E-Verify employer. Any applicant with a disability who requires an accommodation during the application process should contact talent@ceribell.com to request reasonable accommodation.

Privacy Statement For information on how Ceribell processes personal data of job applicants, please review our Privacy Policy.

Compliance Disclaimer If you believe this job posting is non-compliant, please submit a report to legal@ceribell.com. Please note that we will not respond to inquiries unrelated to job posting compliance.

Read the full description
Healthcare Director/Head, Pharmacovigilance at Orca

Leads pharmacovigilance and drug safety operations for a biotech company, overseeing safety data analysis, regulatory compliance, and a small team.

Lead Posted 2 days ago RemoteFirstJobs Product
What this role involves

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

Key Responsibilities

  • Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
  • Responsible for providing safety-related content for all clinical and regulatory documents.
  • Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
  • Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
  • Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
  • Represent product safety in the cross-functional team environment.
  • Lead safety governance activities in collaboration with medical monitors and leadership.
  • Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
  • Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

Qualifications

  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
  • 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
  • Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
  • Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
  • Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
  • Experience with clinical development, risk/benefit analysis, and safety assessment.
  • Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
  • Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
  • Hands-on mentality, ability to operate in a small biotech environment.
  • Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
  • Expertise in analyzing safety data from clinical and safety databases.
  • Experience in MedDRA coding and search strategies.
  • Excellent independent judgment based on knowledge and expertise.
  • Strong personal time management and project management skills.

$200,000 - $245,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Read the full description
Healthcare Pharmacy Technician (Seasonal) at SmithRx

Assists members, providers, and pharmacies with prescription coverage verification, prior authorization requests, and drug access coordination within a pharmacy benefit management platform.

Junior Posted 2 days ago RemoteFirstJobs Product
What this role involves

Who We Are:

SmithRx is a rapidly growing, venture-backed Health-Tech company.  Our mission is to disrupt the expensive and inefficient Pharmacy Benefit Management (PBM) sector by building a next-generation drug acquisition platform driven by cutting edge technology, innovative cost saving tools, and best-in-class customer service.  With hundreds of thousands of members onboarded since 2016, SmithRx has a solution that is resonating with clients all across the country.

We pride ourselves for our mission-driven and collaborative culture that inspires our employees to do their best work. We believe that the U.S healthcare system is in need of transformation, and we come to work each day dedicated to making that change a reality. At our core, we are guided by our company values:

  • Integrity: Our purpose guides our actions and gives us confidence in the path ahead. With unwavering honesty and dependability, we embrace the pressure of challenging the old and exemplify ethical leadership to create the new.
  • Courage: We face continuous challenges with grit and resilience. We embrace the discomfort of the unknown by balancing autonomy with empathy, and ownership with vulnerability. We boldly challenge the status quo to keep moving forward—always.
  • Together: The success of SmithRx reflects the strength of our partnerships and the commitment of our team. Our shared values bind us together and make us one. When one falls, we all fall; when one rises, we all rise.

Job Summary:

This is a 6 month contract position where you will assist members, providers, pharmacies, and the internal SmithRx teams to navigate complexities of prescriptions to guide timely coverage of clinically appropriate, cost effective medication therapy in accordance with plan benefit design and clinical criteria for coverage.  This may involve coordination of clinical review cases, checking coverage and plan rules, verification of submitted information, pharmacy and provider outreach, review of prior authorization requests within established protocols, and assisting to triage and troubleshoot questions and escalations. At SmithRx, we design customized benefit plans for our customers and you are at the forefront of helping navigate and execute drug access.

What you will do:

  • Verify eligibility and drug coverage under the plan benefit design to determine appropriate claims processing
  • Responsible for triaging the process of clinical review for prior authorization requests at different levels as per established protocols
  • Review prior authorization and similar requests under protocol using prior authorization criteria, claims history and plan benefit rules, including prescriber/pharmacy outreach to verify and gather complete required information
  • Organize and prioritize multiple requests internally and externally to ensure timely prior authorization case management.
  • Build and adjust authorizations under protocol within the claim adjudication system
  • Use pharmacy technician experience to navigate drug products, formulations, and perform basic calculations to check and monitor accurate claims adjudication.
  • Ability to critically assess and synthesize multiple workflows together in order to make a sound clinical decision
  • Work across teams to coordinate outreach, address questions/escalations, and help guide processes and protocols for timely and appropriate medication coverage.
  • Evaluate member clinical situation against medication policies and make a determination to approve or triage to Pharmacist for denial
  • Critically assess when medications need to be sent for internal or external review based on synthesizing multiple protocols together
  • Reach out to select external stakeholders for approval on drugs with dollar limits

What you will bring to SmithRx:

  • High School diploma or GED or equivalent work experience
  • Active Pharmacy Technician license required
  • 2-4 years of experience as a Pharmacy Technician
  • 2+ years of experience in prior authorization review (specifically working on the approval side at a PBM or health plan) preferred
  • Proficiency in Mac, MS Office, G-Suite required
  • Critical thinking to navigate complex customized benefit plans to make sound clinical decisions
  • Active listening, conversational speaking skills, with a high degree of empathy
  • Self-starter with ability to multitask, prioritize and manage time effectively
  • Ability to communicate clearly, present complex information to members, clients, pharmacies, providers, and other teams internally
  • Ability to work accurately within protocols and follow appropriate escalation pathways for unique situations or where clarification is needed.

Eligibility & Pay Transparency:

Our company is currently able to offer remote contract employment for this position exclusively to candidates residing in the following states: AR, AZ, FL, GA, KS, MO, OH, TN, TX, UT, VA, and WI.

Please note that automated job board settings may display pay transparency details for additional states. However, we are unable to extend contract offers or hire individuals located outside of the listed eligible states at this time.

Zone A includes the following locations:

  • San Francisco Bay Area - California
  • Metro New York City - Connecticut, New Jersey, New York and Pennsylvania

Zone A Pay Range

$22—$22 USD

Zone B includes the following locations:

  • California - outside of San Francisco Bay Area
  • Metro Denver / Boulder - Colorado
  • Metro District of Columbia - District of Columbia, Maryland, Virginia and West Virginia
  • Metro Boston / Cambridge - Massachusetts and New Hampshire
  • Metro Austin - Texas
  • Metro Seattle - Washington

Zone B Pay Range

$22—$22 USD

Zone C includes all other locations not listed above, including:

  • Alabama, Alaska, Arizona, Arkansas, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Wisconsin, Wyoming
  • Non metro Colorado, Connecticut, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Virginia, Washington, and West Virginia

Zone C Pay Range

$22—$22 USD

Compensation & Benefits

  • Base Salary: The range listed above reflects our standard pay scale and actual pay will vary based on work location, job level, job-related knowledge, skills, and experience.
  • Total Rewards: In addition to base pay, this role may be eligible for bonuses, commissions, or equity. SmithRx offers a variety of benefits to help you live well, including: time off programs, medical, dental, vision, mental health support, paid parental leave, life and disability insurance and 401(k).

Individual offers are tailored to your geography, experience, skills, and education. Your recruiter can share more specific details during the hiring process. In the meantime, feel free to explore our comprehensive benefits here.

Read the full description
Healthcare Director/Head, Pharmacovigilance at Orca

Leads pharmacovigilance and drug safety operations for a biotech company, overseeing risk management, regulatory compliance, and a small safety team.

Lead Posted 2 days ago RemoteFirstJobs Product
What this role involves

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

Key Responsibilities

  • Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
  • Responsible for providing safety-related content for all clinical and regulatory documents.
  • Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
  • Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
  • Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
  • Represent product safety in the cross-functional team environment.
  • Lead safety governance activities in collaboration with medical monitors and leadership.
  • Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
  • Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

Qualifications

  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
  • 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
  • Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
  • Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
  • Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
  • Experience with clinical development, risk/benefit analysis, and safety assessment.
  • Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
  • Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
  • Hands-on mentality, ability to operate in a small biotech environment.
  • Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
  • Expertise in analyzing safety data from clinical and safety databases.
  • Experience in MedDRA coding and search strategies.
  • Excellent independent judgment based on knowledge and expertise.
  • Strong personal time management and project management skills.

$200,000 - $245,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Healthcare Psychiatric Nurse Practitioner - California (Part-time) at Two Chairs

Psychiatric Nurse Practitioner conducts remote mental health assessments, prescribes psychiatric medications, and collaborates with clinical teams to provide integrated care.

Mid Remote Posted 2 days ago RemoteFirstJobs Product
What this role involves

Two Chairs is building a new kind of mental health system based on the idea that the status quo isn’t good enough. Industry-best clinician experiences, better client outcomes, groundbreaking innovation, and access to the highest quality care are how we’ll raise the bar for the entire industry. With that, we’re excited and honored to have been recognized as a 2025 Great Place to Work and 2025 Fortune’s Best Workplaces in Healthcare .

One of our company values is “Embrace Differences” and diversity, equity, inclusion, and belonging are the principles guiding how we build our business and teams. We encourage interested candidates from all backgrounds to apply even if they don’t think they meet some expectations of the role.

Why Two Chairs is consistently a Great Place to Work

  • Competitive Pay: Earn a total hourly rate of $62–$96 (guaranteed base + incentive potential), paid semi-monthly. Base rate determined by clinical experience, place of residence, and overall qualifications.
  • Truly Flexible Work: Work remotely with a schedule that fits your life: no nights, no weekends, no on-call responsibilities. We also provide paid administrative time so documentation doesn’t follow you home.
  • Mission-Driven, Clinician-Led: We’re dedicated to creating a world where everyone has access to exceptional mental healthcare. Clinical decisions are made by clinicians for clinicians, ensuring you’re supported by a team that is focused on centering the client and enabling clinicians to deliver exceptional care.
  • Clinical Excellence Comes First: You’ll join a deeply collaborative environment, with access to physician partners, therapists, and crisis support services. Our integrated platform provides tools that enable measurement-based care, clinical decision support, and seamless information sharing.

What You’ll Do

  • Conduct 60-minute psychiatry assessments and 30-minute follow-up sessions remotely.
  • Prescribe and manage psychiatric medications, including controlled substances, in accordance with state and federal regulations.
  • Integrate brief psychotherapy when clinically appropriate to support your clients in reaching their goals efficiently and sustainably.
  • Collaborate with physicians and clinical leadership for support, escalation, and continued learning.
  • Partner with therapists and other providers through integrated care plans, shared treatment insights, and team consultation spaces.
  • Use data-informed tools and measurement-based care to tailor treatment plans and improve outcomes.
  • Contribute to a growing, diverse community of clinicians committed to redefining mental health care.

What success looks like

In your first 90 days

You will become comfortable with Two Chairs systems, processes, and teams, supported by an onboarding team and clinical leadership. You will gradually build a caseload and deliver exceptional mental health care. You will collaborate with team members and help refine workflows and care protocols.

By the end of your first year

You will have established a robust caseload of clients and delivered exceptional care, as evidenced by clinical outcomes. You will have made contributions to our program and to a world where everyone has access to exceptional mental health care.

What We Offer

  • Compensation you can count on:

    • Competitive Pay: Hourly rate of $62-$96 based on clinical experience, place of residence, and overall qualifications
    • Guaranteed Onboarding Support: Earn 100% of your hourly rate during your initial 90-day ramp period while you build your caseload
    • Sustainable Base + Incentive: Following the ramp period, you’ll receive a guaranteed base (80% of your hourly rate) plus an incentive structure that rewards clinical productivity and the integration of psychotherapy
    • Comprehensive Coverage: we pay for administrative time, clinical consultations, trainings, and no-shows.
    • Long-term Growth: Eligibility for annual performance-based merit increases
  • Comprehensive Benefits:

    • Sick leave
    • Access to 401(k) retirement plan options
    • Credentialing and cross-licensing support
    • License renewal fee reimbursement
    • Technology package including laptop, EHR system, HIPAA compliant video platform, and more
    • Malpractice Insurance provided
    • Supervising Psychiatrist fees covered
  • Flexible Schedule:

    • Part-time, W2 position (up to 16 hours per week) with opportunity for increased hours over time.
    • Expect to spend ~75% of time on direct client care and ~25%  focused on admin/ supervisory work. The balance may vary based on team needs.
    • Build a schedule that works for you within our operating hours of M-F,  8am-8pm.
    • Start date: October 2026
  • Clinical Coverage:

    • Backup coverage, so your clients are supported when you’re away
    • Dedicated 24⁄7 crisis line available for immediate risk assessments and arrangement of in-person interventions if needed

Compensation Ranges

  • Zone 1 / New York City and San Francisco | $80-108/hour

    • New hires can reasonably expect an offer between $80 and $96/hour
  • Zone 2 / Portland, Boston, Chicago, Washington DC, New Jersey, Washington,

all other CA locations | $70-95/hour

  • New hires can reasonably expect an offer between $70 and $86/hour

  • Zone 3 / Miami, Philadelphia, Denver, Austin, Dallas, Houston | $67-91/hour

    • New hires can reasonably expect an offer between $67 and $81/hour
  • Zone 4 / All other locations | $62-87/hour

    • New hires can reasonably expect an offer between $62 and $76/hour

Who You Are

  • A board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP-BC)
  • Licensed to practice in California as a PMHNP (additional licensure a plus!)
  • Open to obtaining additional state licenses to support company expansion. Two Chairs covers all costs and provides full administrative support for the cross-licensing process.
  • 2+ years of experience providing mental health services as a PMHNP
  • Active DEA license in California
  • Experienced in delivering remote telepsychiatry services
  • Passionate about high-quality, measurement-based, collaborative care
  • Eager to join a community of clinicians who are driven by purpose and help us build upon our psychiatry program to improve our services and systems continually
  • Able to start in October 2026

Important Notes:

  • If you need a reasonable accommodation, please let your recruiter know so our People Team can assist you.
  • Please stay alert for job scams: All communication will come from official Two Chairs email domains (@twochairs.com or @twochairscareers.com). See tips from the FTC to avoid job scams: https://www.consumeraffairs.com/news/ftc-offers-tips-on-avoiding-job-scams-041321.html

#LI-REMOTE #ZR

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Healthcare Registered Nurse, Virtual Care - Remote at Tia

Registered Nurse provides virtual clinical support to patients through messaging, phone calls, triage, and care coordination for a women's healthcare platform.

Mid Remote Posted 2 days ago RemoteFirstJobs Product
What this role involves

About Tia

Tia is building a new model for women’s healthcare, one that treats women as whole people, not separate conditions or life stages. By integrating primary care, mental health, gynecology, dermatology, and wellness across both in-person and virtual settings, Tia is improving outcomes, lowering costs, and creating a better experience for patients and providers alike.

About the Role

As a Virtual RN on Tia’s Care Connect team, you will support patients through virtual clinical communication, phone calls, care coordination, and provider inbox support.

You will help patients get timely answers, navigate next steps in their care, and feel supported throughout their Tia experience. This role is a great fit for an RN who is organized, empathetic, comfortable with technology, and excited to work in a fast-paced virtual care environment.

What You’ll Do

  • Respond to patient messages and phone calls in a timely, clear, and empathetic way
  • Triage patient needs and escalate urgent or complex clinical concerns using Tia protocols
  • Support provider inboxes, clinical tasks, medication refills, and care follow-up
  • Communicate lab and imaging results to patients using established workflows
  • Help patients understand next steps in their care and connect them to the right team member when needed
  • Partner with providers, RNs, and care team members to support a high-quality patient experience
  • Maintain accurate documentation and protect patient privacy in accordance with HIPAA

What You’ll Bring

Requirements

  • Graduate of an accredited nursing program; BSN preferred
  • Active Registered Nurse license in California, or ability to obtain California licensure prior to start date
  • 1+ year of healthcare, clinical, or patient-facing experience
  • Experience using EMR systems, clinical messaging tools, and Google Workspace
  • Strong written and verbal communication skills, with the ability to communicate clearly and empathetically with patients
  • Ability to manage multiple patient messages and tasks while staying organized and detail-oriented
  • Comfort working in a fast-paced, virtual care environment
  • Flexibility to work evenings, weekends, and holidays as needed
  • Reliable high-speed internet connection and a quiet, secure workspace suitable for handling confidential patient information

Nice to Have

  • RN licensure in New York and/or Arizona
  • Telehealth, primary care, women’s health, or ambulatory care experience
  • Experience with medication refills, lab results, imaging follow-up, or clinical triage

Work Location

This is a remote role. You must maintain a quiet, secure, HIPAA-compliant workspace and reliable internet connection. #LI-Remote

Compensation & Benefits

Tia is committed to pay equity and pay transparency. Compensation for this role will be based on experience, qualifications, location, role leveling, business needs, and market conditions.

The expected compensation range for this role is: $40 - $45 per hour.

You are also eligible for:

  • Medical, dental, and vision benefits
  • Paid time off, sick leave, and holidays
  • License, certification, or continuing education reimbursement
  • Clinical education resources, such as UpToDate

#LI-AF1

About Tia

Tia is on a mission to transform healthcare for women by increasing access, improving outcomes, and delivering a better care experience. Our “Whole Woman, Whole Life” model integrates primary care, gynecology, mental health, dermatology, and wellness across in-person care and a national virtual platform.

We are a Series D, venture-backed company trusted by more than 120,000 women across four markets. Through our technology-enabled care model and partnerships with leading health systems, Tia is building one of the most comprehensive preventive care models for women.

About Tia’s Culture

Tia is building a culture of excellence in people, process, and product. For us, excellence is not perfection. It is the ongoing pursuit of improvement through learning, reflection, experimentation, curiosity, grit, and care for ourselves and others. We are looking for people who are energized by building, iterating, asking why, and helping create a fundamentally better healthcare experience for women.

This position may require attendance at company and team off-sites.

Scam Notice

Tia will never ask for payment, gift cards, or sensitive financial information during the hiring process. All communication from our team will come from an official company email address ending in @asktia.com. If something feels off, please contact peopleservices@asktia.com.

Equal Opportunity

Tia is an equal opportunity employer. We believe diversity of experience, perspectives, and background leads to a better environment for our employees and a better product for our users and patients. We strongly encourage people of color and members of the LGBTQ+ community to apply.

If you are committed to collaborative problem solving, high-quality work, and making waves in women’s healthcare, we’d love to hear from you.

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Healthcare Experienced CRA - Norway

Experienced Clinical Research Associate monitors study sites and ensures compliance with protocols, regulations, and sponsor requirements for clinical trials.

Senior Remote Posted 3 days ago Himalayas
What this role involves
Job Title: Experienced CRA - Norway Job Location: Oslo, Norway Job Location Type: Home-based Job Contract Type: Full time Job Seniority Level: Experienced CRA - NorwayJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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Healthcare Senior Clinical Research Associate (Chile) at pfm medical, inc.

Oversees clinical research study sites, manages regulatory compliance, monitors data quality, and mentors junior staff on complex trials across Latin America.

Senior Posted 3 days ago RemoteFirstJobs Product
What this role involves

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Chile!

As a Senior CRA you’ll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

  • Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
  • Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
  • Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
  • If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
  • Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
  • Communicates effectively and proactively with both site personnel and Precision’s Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
  • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision’s high quality and professional image
  • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
  • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
  • Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
  • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
  • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
  • Assists the team managers in the preparation and review of protocols and other study documentation
  • Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
  • Assists with review of clinical study reports
  • Functions as a mentor, assisting with the training and developing of new employees and junior monitors
  • Interacts with client, participates in proposal activities, including development and client presentations
  • Initiates payment requests for investigators
  • Travels as necessary according to project needs
  • Other job duties as assigned

Minimum Education & Experience:

  • 4-year college degree or equivalent experience in a scientific or healthcare discipline
  • 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
  • Significant site management experience or equivalent experience in clinical research
  • Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

  • Graduate, postgraduate degree
  • Experience monitoring in rare and complex therapeutic areas
  • Experience monitoring EDC trials and EHR records
  • Experience in biopharma or relevant therapeutic area
  • Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
  • Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
  • Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
  • Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
  • Select opportunities require Oncology experience preferably in early phases
  • Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
  • Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
  • Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
  • Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

Read the full description
Healthcare Senior Clinical Research Associate (Brazil) at pfm medical, inc.

Oversees clinical research study sites in Brazil, managing regulatory compliance, patient safety, data quality, and monitoring visits for pharmaceutical trials.

Senior Onsite Posted 3 days ago RemoteFirstJobs Product
What this role involves

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Brazil!

As a Senior CRA you’ll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

  • Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
  • Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
  • Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
  • If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
  • Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
  • Communicates effectively and proactively with both site personnel and Precision’s Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
  • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision’s high quality and professional image
  • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
  • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
  • Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
  • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
  • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
  • Assists the team managers in the preparation and review of protocols and other study documentation
  • Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
  • Assists with review of clinical study reports
  • Functions as a mentor, assisting with the training and developing of new employees and junior monitors
  • Interacts with client, participates in proposal activities, including development and client presentations
  • Initiates payment requests for investigators
  • Travels as necessary according to project needs
  • Other job duties as assigned

Minimum Education & Experience:

  • 4-year college degree or equivalent experience in a scientific or healthcare discipline
  • 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
  • Significant site management experience or equivalent experience in clinical research
  • Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

  • Graduate, postgraduate degree
  • Experience monitoring in rare and complex therapeutic areas
  • Experience monitoring EDC trials and EHR records
  • Experience in biopharma or relevant therapeutic area
  • Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
  • Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
  • Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
  • Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
  • Select opportunities require Oncology experience preferably in early phases
  • Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
  • Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
  • Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
  • Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

Read the full description
Healthcare Telepsychiatrist (Contract, Part Time)

Provides psychiatric consultation and treatment to patients through telehealth, delivering remote mental health care services.

Senior Remote Posted 3 days ago Jobicy AI
What this role involves
About Solace Healthcare in the U.S. is fundamentally broken. The system is so complex that 88% of U.S. adults do not have the health literacy necessary to navigate it without...
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Healthcare Medical Director -Pharmacy Appeals

Medical director reviews Medicare drug appeals using clinical expertise to make coverage determinations for Part D and Part B medications.

Senior Posted 3 days ago Himalayas
What this role involves
Become a part of our caring community The Medical Director relies on broad clinical expertise to review Medicare drug appeals (Part D & B).
Read the full description