Senior Medical Writer

BioMarin Pharmaceutical Inc.; San Rafael (CA); On-site; USD 142,100 - 195,360; Full time

Benefits offered by this job

Company-sponsored medical insurance

Annual discretionary bonus

Comprehensive benefits package

Job summary

A global biotechnology company in San Rafael is seeking a Senior Medical Writer who will manage clinical documentation and project management skills to develop and finalize vital documents used in clinical studies. The ideal candidate will have a strong background in medical writing, a Bachelor’s or higher degree, and the ability to handle multiple tasks while ensuring regulatory compliance. This role offers competitive compensation and a comprehensive benefits package.

Qualifications

• Up to 6 years as a medical writer in pharma or 10 years in medical writing.
• Experience writing and editing protocols and clinical study reports.
• Proficient in style guides and regulatory guidance.

Responsibilities

• Draft and edit clinical study documents.
• Manage study-team participation and meetings.
• Collaborate with cross-functional groups to meet needs.

Skills

Clinical study document drafting and editing

Project management skills

Scientific communication

Regulatory requirements knowledge

Education

Bachelor's or higher degree

Tools

Microsoft Word

Adobe Acrobat

Veeva

Job description

Who We Are

BioMarin is a global biotechnology company relentlessly pursuing bold science to translate genetic discoveries into new medicines that advance human health.

Since 1997 we have harnessed genetics and molecular biology to develop transformative medicines for patients with significant unmet medical need, producing a diverse pipeline of first‑to‑market therapeutic candidates.

Our Worldwide Research and Development (WWRD) engine spans bench, clinical research and post‑market clinical development, with teams focused on creating first‑in‑class and best‑in‑class therapeutics.

Role

The Senior Medical Writer applies advanced documentation and project‑management skills to develop, draft, review, edit, and finalize documents used in clinical studies and regulatory submissions.

Responsibilities

• Draft and edit clinical study documents, including protocols, protocol amendments, informed‑consent forms, and clinical study reports.
• Prepare aggregate safety and efficacy documents such as investigator’s brochures and periodic safety reports (PBRERs, DSURs).
  Prepare regulatory filings, e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries.
• Manage study‑team participation, including scheduling meetings, developing timetables, and adjudicating document reviews.
• Represent Global Medical Writing at cross‑functional meetings.
• Build partnerships with cross‑functional groups to meet stakeholder needs.
• Provide peer‑review and editing support for regulatory documents such as statistical analysis plans and CRFs.
• Assist in developing and reviewing standard processes, templates and best practices within Global Medical Writing and other departments.
• Adhere to departmental procedures, industry standards and technical requirements.
• Collaborate effectively with cross‑functional groups within BioMarin.
• Other tasks as assigned.

Scope

• Progressively develop the medical writing function in alignment with Development Sciences goals.
• Reduce CRO and contractor costs, increase productivity, and realize efficiencies and consistent documentation quality through repeatable processes and continuity.

Requirements

Experience

• Up to 6 years as a medical writer in the pharmaceutical industry OR at least 10 years of medical/scientific writing experience as primary job responsibility.

Medical Writing

• Experience writing, reviewing, or editing protocols and clinical study reports.
• Preferred experience with INDs, BLA/NDAs, PBRERs, DSURs, PAERs and regulatory briefing books.
• Applied knowledge of style guides (AMA, Chicago, etc.) and regulatory guidance.
• Ability to interpret and create complex tabular and graphical clinical data presentations.
• Advanced knowledge of basic clinical lab tests and coding dictionaries (MedDRA, WHO Drug).

Clinical Studies

• Advanced understanding of drug development, biostatistics, clinical research concepts, data collection and database management.
• Intermediate to advanced knowledge of non‑clinical development, CMC, PK, PD and antibody detection.
• Direct experience documenting all phases of drug development.

Regulatory

• Intermediate to advanced knowledge of regulatory requirements for stand‑alone documents (protocols, investigator brochures, clinical study reports).
• Familiarity with eCTD IND/NDA and modules 2‑5, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).

Project Management

• Capable of handling multiple tasks, shifting priorities and leading cross‑functional teams under strict timelines.
• Skilled at conflict resolution, advocating for Global Medical Writing and collaborating with line management.

Communication

• Clear, concise written and verbal communication.
• Ability to translate complex scientific concepts into regulatory‐compliant text.
• Effective presentation skills, serving varied audiences.

Education

• Bachelor’s or higher degree required; scientific focus desirable.
• Evidence of medical writing career development (e.g., AMWA certificate, Editor in Life Sciences, DIA training) desirable.

Computer Skills

• Proficiency in Microsoft Word, Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint.
• Experience with document‑management software (LiveLink, SharePoint, Veeva).
• Basic scanner, printer, and copier operation.

Equal Opportunity Employer

BioMarin is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

Benefits

Benefits include company‑sponsored medical, dental, vision, and life insurance plans, discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off, and a comprehensive benefits package. To learn more, visit https://careers.biomarin.com/benefits.

Compensation

Salary range: $142,100 to $195,360, depending on experience, qualifications and location.