Expert Medical Writer

Expert Medical Writer

Viatris

Allschwil, Switzerland

The Role & What You Will Be Doing

The Expert Medical Writer provides strategic, scientific, and operational leadership for the planning, authoring, and coordination of high-impact clinical and regulatory documents that support global marketing applications. In addition to hands-on writing, the role serves as Programme Medical Writer for complex submissions, drives documentation strategy across therapeutic areas, mentors a team of writers, and champions continuous improvement of writing processes with a specific focus on new technologies.

Every day, we rise to the challenge to make a difference and here’s how the Expert Medical Writer role will make an impact:

• Program‐level leadership – Lead, oversee, and coordinate medical‑writing deliverables for full CTD submissions across multiple development programs (e.g., clinical‑overview and summary modules) ensuring scientific integrity, consistency, and on‑time delivery;
• Scientific & strategic contribution – Act as subject‑matter expert on regulatory requirements; provide guidance on data‑pooling, analysis plans, and document positioning to study and submission teams;
• Authoring/reviewing – Independently write or critically review CSRs, CTD Module 2 documents, responses to agency questions, briefing packages, 120‑day safety updates, PIPs, investigator brochures, and other documents as needed;
• Cross‑functional collaboration – Partner with Clinical, Biostatistics, Clinical Pharmacology, Drug Safety, CMC, Regulatory Affairs, and other stakeholders to align data presentation and messaging;
• People & vendor management – Supervise Senior/Regulatory Writers and Disclosure managers; provide coaching, performance feedback, and professional development. Manage outsourced writing vendors, ensuring quality and budget adherence;
• Process/technology improvement – Initiate and drive cross‑functional initiatives to enhance templates, authoring tools, and quality systems related to regulatory writing with a focus on AI and other innovative technologies.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• BSc in Life Sciences or equivalent;
• Over 7 years’ medical‑writing experience in pharma/biotech with multiple successful global submissions; leadership of one or more junior-level writers;
• Advanced knowledge of global regulatory guidelines;
• Proven ability to interpret and present complex scientific data clearly;
• Excellent written & spoken English;
• Ability to set priorities, manage risk, and meet aggressive timelines;
• Track record of mentoring writers and influencing senior stakeholders.