Senior Manager, Clinical Medical Writer

Working with Us

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 : 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 Masters 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

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.

#RayzeBio

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview :

• San Diego - RayzeBio - CA : $164846 - $199754

The starting compensation range(s) for this role are listed above 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 employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : 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). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility / infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work Life-changing Careers

With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company 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.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information : data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Required Experience :

Senior Manager

Key Skills

Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1