Senior Manager, Clinical Medical Writer

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

We are seeking an experienced Clinical Medical Writer with strong project management capabilities to join our growing clinical development team. This hybrid role combines the 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 Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state or regional 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 3years 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 and radiopharmaceuticals 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 and able to drive decision making