Senior Manager, Clinical Medical Writer

Bristol Myers Squibb

1d • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience with oncology products required and radiopharmaceuticals a plus.
• 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

Responsibilities

• 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.
• 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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees