Senior Medical Writer

BIOMARIN; London; On-site; GBP 50,000 - 75,000; Full time

Job summary

A leading biotechnology company in London is seeking a Senior Medical Writer to draft and manage clinical study documents. This role involves collaboration with cross-functional teams to ensure the production of high-quality regulatory submissions and reports. The ideal candidate will have a relevant bachelor's degree, up to 10 years of experience in medical writing, and strong project management skills. The position offers a chance to contribute to transformative medicines for patients with genetic conditions.

Qualifications

• 3-10 years of medical writing experience in the pharmaceutical industry.
• Experience with INDs, BLAs, and regulatory documents preferred.
• Advanced understanding of the drug development process.

Responsibilities

• Draft and edit clinical study documents and reports.
• Manage document preparation and cross-functional team participation.
• Ensure adherence to regulatory requirements and best practices.

Skills

Advanced medical writing skills

Project management skills

Interpersonal skills

Regulatory knowledge

Technical writing

Education

Bachelor’s degree or higher

Tools

Microsoft Word

Excel

Adobe Acrobat

MS Project

Job description

Overview

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since 1997, we have applied our scientific expertise to understand the underlying causes of genetic conditions and create transformative medicines using multiple treatment modalities. Our approach combines genetics and molecular biology to develop medicines for patients with significant unmet medical need. We seek the best people with the right technical expertise and a drive to solve real problems, creating an environment that empowers bold, innovative science. Our diverse pipeline includes commercial, clinical, and preclinical candidates with well-understood biology offering opportunities to be first-to-market or to provide substantial benefits over existing options.

Worldwide Research and Development (WWRD) spans research, discovery, and post-market clinical development. Our teams work on first-in-class and best-in-class therapeutics that meaningfully advance patients with genetic diseases. The Senior Medical Writer applies advanced documentation preparation and project management skills to assist in the development, drafting, review, editing, and finalization of documents used in clinical studies and for regulatory submissions and publications.

Responsibilities

• Draft and edit documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports.
• Draft and edit documents used in reporting aggregate safety and efficacy information for a molecule, such as investigators' brochures and periodic safety reports (PBRERs, DSURs, etc.).
• Draft and edit documents for regulatory filings (e.g., briefing books, eCTD Module 2/Module 5 clinical or integrated summaries).
• Manage study team participation in document preparation, including calling/running meetings, developing and managing timelines, and overseeing the document review and comment adjudication processes.
• Represent Global Medical Writing at cross-functional team meetings (e.g., study team, development team, other subteams).
• Build effective partnerships with cross-functional groups to meet customer and stakeholder needs.
• Provide peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials.
• Assist in developing and reviewing standard processes and templates within Global Medical Writing and consult on standard processes in other departments as needed.
• Adhere to departmental procedures, technical standards, and industry best practices during all aspects of work.
• Collaborate effectively with cross-functional groups within BioMarin.
• Perform other tasks as assigned.

Scope

This position develops the medical writing function in alignment with Development Sciences and organizational goals. Hiring a regular full-time employee is expected to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity, and improve documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.

Education

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

Experience

Relevant experience:

• Up to 6 years of medical writing experience in the pharmaceutical industry, or
• At least 10 years of medical or scientific writing experience as a primary job responsibility.

Clinical Studies requirements include:

• Advanced understanding of the drug development process (discovery to market), biostatistics and clinical research concepts, clinical study conduct, data collection, database management, data integration, and dataset generation.
• Intermediate to advanced understanding of nonclinical development, CMC, PK, PD, and antibody detection.
• Documentation required for clinical studies; protocol design (objectives, endpoints, AE/SAE collection and reporting); study results reporting; integrated results reporting.
• Direct experience with documentation in all phases of drug development.

Medical Writing capabilities:

• Experience writing, reviewing, or editing protocols and clinical study reports.
• Experience with INDs, BLA/NDAs, PBRERs, DSURs, and PAERs is highly preferred.
• Experience with regulatory briefing books preferred.
• Advanced knowledge of style guides, dictionaries, and guidance documents; ability to interpret and create complex data presentations.
• Understanding of coding dictionaries (MedDRA, WHO Drug).

Technical and regulatory skills:

• Proficient in Microsoft Word (templates), Excel, Adobe Acrobat, MS Project/Project Server, PowerPoint; experience with document management software (e.g., LiveLink, SharePoint, Veeva).
• Familiar with regulatory requirements for standalone documents (protocols, investigators brochures, clinical study reports); experience with eCTD modules 2, 3, 4, 5 and ISS/ISE where applicable.

Project Management and Communication:

• Ability to manage multiple tasks and shifting priorities; lead cross-functional teams under tight timelines; represent Global Medical Writing in cross-functional meetings; resolve cross-functional conflicts; strong conflict resolution and initiative; detail-oriented; clear written and verbal communication; ability to simplify complex scientific concepts for regulatory audiences.

Note

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assigned.

Equal Opportunity Employer/Veterans/Disabled

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.