Medical Writer, Scientific Communications
Penumbra IncSalary not specified
Full Time
Mid-level (3 to 4 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Radiopharmaceuticals, OncologyIndustries
Requirements
- 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
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
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Bristol Myers Squibb offer?
Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.
Is this a remote or hybrid role?
This is a hybrid role.
What skills are required for the Senior Manager, Clinical Medical Writer position?
The role requires strong scientific writing expertise for clinical and regulatory documents, project management capabilities including oversight of vendors and timelines, strategic thinking, and cross-functional coordination skills.
What is the company culture like at Bristol Myers Squibb and RayzeBio?
The culture is challenging, meaningful, and life-changing, with uniquely interesting work, high-achieving teams, opportunities for growth, and emphasis on balance and flexibility in a fast-paced, collaborative environment.
What makes a strong candidate for this role?
A strong candidate is an experienced clinical medical writer who is a strategic thinker with hands-on writing expertise, strong project management skills, and the ability to lead projects while ensuring compliance with ICH, GCP, FDA regulations, and SOPs.
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Benefits
Flexible Work Hours
Hybrid Work Options
Professional Development Budget
Risks
Increased competition in oncology from emerging biotech firms like ArsenalBio.
BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.
Rapid AI and digital tech evolution may pose integration challenges for BMS.
Differentiation
BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.
The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.
BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.
Upsides
BMS's partnership with Medidata enhances clinical research processes and patient outcomes.
The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.
BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.
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