Technical Writer - Regulatory Submission – 6953

About

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Technical Writer for Regulatory Submission.

The start date is asap for a 24 month-contract based in Basel area with high chances of extension.

The Technical Writer is responsible for independently authoring and reviewing high-quality clinical regulatory documents that support global health authority submissions. They provide strategic and scientific input to clinical and submission teams, helping shape data presentation, regulatory positioning, and document strategy. The position collaborates extensively with cross-functional partners and manages interactions with external writing vendors to ensure timely, high-quality deliverables. Additionally, the Senior Regulatory Writer mentors junior writers and contributes to the continuous strengthening of the organization’s regulatory writing capabilities.

Main Responsibilities

• Autonomously write and/or review clinical regulatory documents such as CTD Module II summaries and Clinical Overviews, Clinical study reports (CSRs), and other regulatory documents, as needed, such as Responses to Health Authority questions, Briefing books, 120-day Safety updates, Pediatric investigational plans, or Investigator brochures.
• Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing, e.g., provide input on pooling strategy, provide content expertise and guidance on regulatory requirements.
• Contribute to the planning of data analyses and presentation for CSRs; review statistical analysis plans and related documents.
• Effectively collaborate with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC and Regulatory Affairs.
• Work together with the in-house Documentation Specialist(s) to produce high-quality final documents and ensure timely delivery.
• Lead or assist with the selection and management of external regulatory writing services.
• Mentor/train less experienced writers.

Qualifications and Experience

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
• Bachelor's degree or equivalent in Life Sciences is required and a Master’s degree is preferred.
• 5 years of experience as a regulatory/medical writer in the pharmaceutical industry across several therapeutic areas are required.
• Well-developed and proven medical writing skills.
• Knowledge of regulatory document requirements and guidelines.
• The ability to develop and mentor more junior medical writers.
• The ability to work independently and as part of a team.
• The ability to work under pressure and meet challenging deadlines.
• Excellent interpersonal and presentation skills.
• English fluent proficiency required for this role.