Senior Manager, Clinical Medical Writer

Senior Manager, Clinical Medical Writer at Bristol Myers Squibb

Working at Bristol Myers Squibb offers a challenging, meaningful, and life-changing experience. You'll contribute to work that transforms patients' lives and fosters career growth through unique opportunities and high-achachieving teams. Bristol Myers Squibb values balance and flexibility, offering competitive benefits, services, and programs to support employees' professional and personal goals.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. They are dedicated to improving cancer patient survival by leveraging targeted radioisotopes. RayzeBio focuses on developing innovative drugs against solid tumor targets, aiming to be a global leader in radiopharmaceuticals under the guidance of an experienced entrepreneurial team.

We are seeking an experienced Senior Manager, Clinical Medical Writer with strong project management capabilities to join our growing clinical development team. This remote 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, adhering to 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 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.

If a role at Bristol Myers Squibb intrigues you but doesn't perfectly align with your resume, we encourage you to apply. You could be one step away from work that will transform your life and career.

Compensation Overview

The starting compensation range for this full-time remote role in the United States is $149,860 - $181,595. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation is determined by job characteristics, required skills, work location, schedule, knowledge, and experience.

Benefits

Benefit offerings vary by job and location and are subject to plan terms. Our comprehensive benefits include: Health Coverage (medical, pharmacy, dental, vision), Wellbeing Support (BMS Well-Being Account, Living Life Better, EAP), Financial Well-being and Protection (401k, short/long-term disability, life insurance, etc.). Work-life benefits include Paid Time Off, with flexible time off for US Exempt Employees (with manager approval) and 11 paid national holidays (exceptions for Phoenix, AZ, Puerto Rico, and RayzeBio employees, who receive 160 hours annual paid vacation, 11 national holidays, and 3 optional holidays).

Based on eligibility, additional time off may include unlimited paid sick time, volunteer days, summer hours flexibility, leaves of absence (medical, personal, parental, caregiver, bereavement, military), and an annual Global Shutdown between Christmas and New Year's Day.

All global full and part-time employees actively employed and paid directly by BMS at year-end are eligible for the Global Shutdown. Eligibility for summer hours varies by role and location; field sales, manufacturing operations, and capability centers may have limitations. Remote-by-design or lab-based roles may be eligible, pending manager discussion. Contractors and service providers are not eligible.

Uniquely Interesting Work, Life-changing Careers

With a vision to 'Transform patients' lives through science,' every BMS employee contributes significantly. We empower individuals to apply their talents and perspectives in a supportive culture, promoting global clinical trial participation. Our shared values of passion, innovation, urgency, accountability, inclusion, and integrity maximize the potential of all colleagues.

On-site Protocol

BMS uses an occupancy structure (site-essential, site-by-design, field-based, remote-by-design) to define work location based on role responsibilities. Site-essential roles require 100% on-site presence. Site-by-design roles may be hybrid with at least 50% on-site. Field-based and remote-by-design roles require the ability to travel for customer, patient, partner visits, and meetings as directed.

Supporting People With Disabilities

BMS is committed to supporting people with disabilities through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support. Applicants can request accommodations before accepting a job offer. Inquiries for application process accommodations should be directed to adastaffingsupport@bms.com. Refer to careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

Candidate Rights

BMS considers qualified applicants with arrest and conviction records in accordance with applicable laws. Residents of Los Angeles County should visit careers.bms.com/california-residents for additional information.

Data Protection

BMS will never request payments, financial information, or social security numbers during the application or recruitment process. Learn more about fraud protection at careers.bms.com/fraud-protection. Any data processed for applications will be handled according to applicable privacy policies and regulations. For missing or incorrect job posting information, contact TAEnablement@bms.com, providing the Job Title and Requisition number. Do not send application-related communications to this email; direct status inquiries to Chat with Ripley.

Requisition: R1596089

Key skills/competency

• Clinical Medical Writing
• Regulatory Submissions
• Oncology
• Project Management
• ICH/GCP Guidelines
• eCTD
• Clinical Data Interpretation
• Cross-functional Collaboration
• Document Management Systems
• Radiopharmaceuticals