Bristol Myers Squibb
Senior Manager, Clinical Medical Writer
Bristol Myers Squibb, San Diego, California, United States, 92189
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Working with Us Caring for patients while driving scientific innovation is what drives us. At Bristol Myers Squibb, every day brings inspiring work, from refining production lines to pioneering breakthrough cell therapies—meaning our employees play a vital role in reshaping patients’ lives and advancing scientific knowledge.
RayzeBio is a dynamic biotechnology company based in San Diego, CA, that improves cancer survival with targeted radioisotopes. It is part of Bristol Myers Squibb and is on a mission to become the global leader in radiopharmaceuticals.
Job Title: Clinical Medical Writer We are seeking an experienced Clinical Medical Writer with strong project‑management capabilities to join our growing clinical development team. The hybrid role combines scientific writing of key clinical and regulatory documents with oversight of medical‑writing vendors, timelines, resources, and cross‑functional coordination. The ideal candidate will be a strategic thinker with hands‑on writing expertise and the ability to lead multiple writing projects in a fast‑paced, collaborative environment, in accordance with SOPs, GCP/ICH guidelines, and applicable federal (FDA) and state regulations.
Job Responsibilities Medical Writing (70%)
Author, edit, QC, and publish high‑quality clinical and regulatory documents in accordance with ICH, GCP, and company standards, including:
Clinical Study Protocols and Amendments
Informed Consent Forms (ICFs)
Investigator Brochures (IBs)
Clinical Study Reports (CSRs)
Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents)
Patient narratives and safety summaries
Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides.
Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders.
Coordinate with cross‑functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations, and other departments) for source data, input, and review.
Project Management (30%)
Oversee planning, timelines, and resource management for medical‑writing deliverables across clinical programs.
Organize and facilitate document review cycles, manage version control, and oversee quality assurance for document finalization and submission.
Track writing assignments and ensure timely execution in line with program milestones and regulatory submission deadlines.
Serve as the primary point of contact for cross‑functional teams regarding medical‑writing deliverables.
Manage outsourcing partners and medical‑writing consultants, when applicable.
Lead regular status meetings, provide risk‑mitigation strategies, and communicate project status to cross‑functional teams.
Education and Experience
Advanced degree (PhD, PharmD, MD, or Master’s in Life Sciences or related field) preferred.
Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry.
At least 2 years of experience managing medical‑writing projects or acting in a lead writer role.
Experience with oncology products required; experience with radiopharmaceuticals is a plus.
Skills and Qualifications
Independent professional who proactively communicates frequently and effectively.
Strong leadership and project‑management skills across complex programs and cross‑functional teams, able to drive decision making.
Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process.
Excellent written and verbal communication skills with strong attention to detail and scientific accuracy.
Proficiency in Microsoft Office Suite, document‑management systems, and project‑tracking tools (e.g., MS Project, Smartsheet, Veeva).
Ability to manage multiple priorities in a matrixed environment with minimal supervision.
Compensation Overview San Diego - RayzeBio - CA: $164,846 - $199,754
Compensation based on experience; may include incentive cash and stock options. Eligibility for specific benefits listed on our careers site may vary by location.
Benefits Medical, pharmacy, dental and vision care; wellbeing support; 401(K); life and disability insurance; paid national holidays, optional holidays, up to 120 hours of paid vacation; parental, caregiver, bereavement, and military leave; family care resources; tuition reimbursement; recognition program.
Uniquely Interesting Work, Life‑Changing Careers Each BMS employee plays an integral role in work that goes beyond ordinary, driven by our vision: Transforming patients’ lives through science™. We empower individuals to apply unique talents in a supportive culture that promotes global participation in clinical trials. Our core values—passion, innovation, urgency, accountability, inclusion, and integrity—bring out the highest potential of our colleagues.
Occupancy and Employment Structure BMS has an occupancy structure that determines where an employee is required to conduct their work. Roles are categorized as site‑essential, site‑by‑design, field‑based, or remote‑by‑design. The corresponding requirement for onsite presence depends on the nature of the role and the responsibilities involved.
Equal Employment Opportunity BMS is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations or adjustments, and ongoing support in their roles. Requests for reasonable accommodations can be directed to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.
COVID‑19 Vaccination Requirement BMS strongly recommends that all employees be fully vaccinated for COVID‑19 and keep up‑to‑date with boosters.
Additional Information for California Residents If you live in or expect to work from Los Angeles County, please visit https://careers.bms.com/california-residents/ for important additional information.
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Get AI-powered advice on this job and more exclusive features.
Working with Us Caring for patients while driving scientific innovation is what drives us. At Bristol Myers Squibb, every day brings inspiring work, from refining production lines to pioneering breakthrough cell therapies—meaning our employees play a vital role in reshaping patients’ lives and advancing scientific knowledge.
RayzeBio is a dynamic biotechnology company based in San Diego, CA, that improves cancer survival with targeted radioisotopes. It is part of Bristol Myers Squibb and is on a mission to become the global leader in radiopharmaceuticals.
Job Title: Clinical Medical Writer We are seeking an experienced Clinical Medical Writer with strong project‑management capabilities to join our growing clinical development team. The hybrid role combines scientific writing of key clinical and regulatory documents with oversight of medical‑writing vendors, timelines, resources, and cross‑functional coordination. The ideal candidate will be a strategic thinker with hands‑on writing expertise and the ability to lead multiple writing projects in a fast‑paced, collaborative environment, in accordance with SOPs, GCP/ICH guidelines, and applicable federal (FDA) and state regulations.
Job Responsibilities Medical Writing (70%)
Author, edit, QC, and publish high‑quality clinical and regulatory documents in accordance with ICH, GCP, and company standards, including:
Clinical Study Protocols and Amendments
Informed Consent Forms (ICFs)
Investigator Brochures (IBs)
Clinical Study Reports (CSRs)
Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents)
Patient narratives and safety summaries
Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides.
Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders.
Coordinate with cross‑functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations, and other departments) for source data, input, and review.
Project Management (30%)
Oversee planning, timelines, and resource management for medical‑writing deliverables across clinical programs.
Organize and facilitate document review cycles, manage version control, and oversee quality assurance for document finalization and submission.
Track writing assignments and ensure timely execution in line with program milestones and regulatory submission deadlines.
Serve as the primary point of contact for cross‑functional teams regarding medical‑writing deliverables.
Manage outsourcing partners and medical‑writing consultants, when applicable.
Lead regular status meetings, provide risk‑mitigation strategies, and communicate project status to cross‑functional teams.
Education and Experience
Advanced degree (PhD, PharmD, MD, or Master’s in Life Sciences or related field) preferred.
Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry.
At least 2 years of experience managing medical‑writing projects or acting in a lead writer role.
Experience with oncology products required; experience with radiopharmaceuticals is a plus.
Skills and Qualifications
Independent professional who proactively communicates frequently and effectively.
Strong leadership and project‑management skills across complex programs and cross‑functional teams, able to drive decision making.
Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process.
Excellent written and verbal communication skills with strong attention to detail and scientific accuracy.
Proficiency in Microsoft Office Suite, document‑management systems, and project‑tracking tools (e.g., MS Project, Smartsheet, Veeva).
Ability to manage multiple priorities in a matrixed environment with minimal supervision.
Compensation Overview San Diego - RayzeBio - CA: $164,846 - $199,754
Compensation based on experience; may include incentive cash and stock options. Eligibility for specific benefits listed on our careers site may vary by location.
Benefits Medical, pharmacy, dental and vision care; wellbeing support; 401(K); life and disability insurance; paid national holidays, optional holidays, up to 120 hours of paid vacation; parental, caregiver, bereavement, and military leave; family care resources; tuition reimbursement; recognition program.
Uniquely Interesting Work, Life‑Changing Careers Each BMS employee plays an integral role in work that goes beyond ordinary, driven by our vision: Transforming patients’ lives through science™. We empower individuals to apply unique talents in a supportive culture that promotes global participation in clinical trials. Our core values—passion, innovation, urgency, accountability, inclusion, and integrity—bring out the highest potential of our colleagues.
Occupancy and Employment Structure BMS has an occupancy structure that determines where an employee is required to conduct their work. Roles are categorized as site‑essential, site‑by‑design, field‑based, or remote‑by‑design. The corresponding requirement for onsite presence depends on the nature of the role and the responsibilities involved.
Equal Employment Opportunity BMS is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations or adjustments, and ongoing support in their roles. Requests for reasonable accommodations can be directed to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.
COVID‑19 Vaccination Requirement BMS strongly recommends that all employees be fully vaccinated for COVID‑19 and keep up‑to‑date with boosters.
Additional Information for California Residents If you live in or expect to work from Los Angeles County, please visit https://careers.bms.com/california-residents/ for important additional information.
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