Senior Principal Medical Writer remote

Bedrijfsomschrijving

About the Company:

A global pharmaceutical leader committed to delivering innovative medicines that address critical health challenges and meet urgent needs for improved treatments.

Job description:

Yacht (Life Sciences) has a vacancy for a (Freelance) Senior Medical Writer to work at a multinational pharmaceutical company, who is willing to work fully remote.

Responsibilities:

The Senior Medical Writer will independently handle a variety of clinical and regulatory writing tasks, which may include:

• Writing and editing clinical study reports (CSRs), Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas. Coordination with contract writers may be required to meet deadlines.
• Reviewing clinical protocols, Statistical Analysis Plans (SAPs), Statistical Programming Plans, data tables, listings, and other regulatory documents as necessary.
• Leading the development of briefing documents, Investigational New Drug (IND) applications, licensing submissions (e.g., BLAs, MAAs), and other complex regulatory documents.
• Negotiating timelines for the preparation of clinical regulatory documents.
• Analyzing and presenting clinical study data with critical thinking.
• Managing the critical review process for regulatory documents and incorporating feedback into successive drafts.
• Providing quality control (QC) support for clinical documents, including cross-checking data and verifying content against source materials.
• Reviewing case report forms, statistical analysis plans, and data outputs for accuracy and compliance with required formats.
• Assisting with or leading the development and revision of standard operating procedures (SOPs), work process documents (WPDs), and document templates. Supporting cross-functional training initiatives for new/revised procedures and templates.
• Participating in clinical project team meetings.
• Engaging in or leading cross-functional meetings and standards committees.
• Ensuring the quality of regulatory documents by adhering to ICH guidelines, Good Clinical Practice (GCP), and other applicable standards.

This position offers an exciting opportunity to contribute to high-quality medical writing projects in a dynamic, multinational setting.

Job Requirements:

Education:

Advanced degree in a scientific discipline (MSc or PhD in biological sciences preferred)

Experience with Documentation:

• Direct experience in authoring key clinical and regulatory documents is essential, including clinical protocols, INDs, BLAs, MAAs, SOPs, clinical study reports (CSRs), Investigator's Brochures, Clinical Trial Results postings, and annual reports.
• This role requires hands-on writing experience in the pharmaceutical or clinical field. Observing, shadowing, or writing articles about these documents is not sufficient.

Professional Experience:

• A minimum of 5+ years writing high-quality clinical and regulatory documents, including CSRs across multiple therapeutic areas.
• Proven experience in writing CSRs for pivotal/registration studies or drafting clinical sections of licensing submissions.
• Expertise in authoring and editing ICH-compliant clinical regulatory documents adhering to the Common Technical Document (CTD) structure.
• Pharmaceutical or biotechnology industry experience is mandatory.

Other skills:

• Proficiency in Microsoft Office applications.
• In-depth familiarity with CTD, ICH, GCP, and other regulatory standards.
• Fluency in English, both written and oral.
• A background in biologics is considered an advantage.

Terms of employment:

This concerns a full-time, remote position for 20-40 hours per week. We will offer a contract for 1 year with the possibility of extension and a fixed contract directly at the company.

This role can be performed as a freelancer within the EU.

Work Location: Remote / Work-from-home

Work Schedule: Flexible schedule of at least 20 hours a week, with the understanding that the workload fluctuates, and the worker may need more hours to complete the work. There are times when work slows, so the client needs writers to understand there might be a drop in hours.

Engagement Model: Freelance/ Independent contractor

Start date: As soon as possible. It takes time to get an onboarding and training on processes at the company.