Senior Manager, Clinical Medical Writer Job at Bristol Myers Squibb in San Diego

Join to apply for the Senior Manager, Clinical Medical Writer role at Bristol Myers Squibb . 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. 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. Hiring Details Seniority Level: Mid‑Senior level Employment Type: Full‑time Job Function: Health Care Provider Industries: Pharmaceutical Manufacturing 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 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. 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 The starting compensation range listed above is for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Benefits Benefit offerings include medical, pharmacy, dental, and vision care; wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP); financial well‑being resources and a 401(k); disability, life, supplemental health, business travel protection, and survivor support; paid national holidays and optional holidays; Global Shutdown Days; up to 120 hours of paid vacation; two paid volunteer days; sick time off; summer hours flexibility; parental, caregiver, bereavement, and military leave; family care services (adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources); tuition reimbursement and a recognition program. Equal Employment Opportunity BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Additional Information BMS strongly recommends that all employees be fully vaccinated for Covid‑19 and keep up to date with Covid‑19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For California residents, see additional information at https://careers.bms.com/california-residents/. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr