[Remote] Senior Manager, Clinical Medical Writer at Bristol-Myers Squibb

United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

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
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

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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