Expert Medical Writer

Viatris; Allschwil; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Pension scheme

Lunch allowance

Development opportunities

Zusammenfassung

Viatris is seeking an Expert Medical Writer in Allschwil, Switzerland, who will provide strategic and operational leadership for clinical and regulatory document authoring. The successful candidate will oversee multiple submissions, mentor writers, and enhance writing processes, particularly using innovative technologies.

Requirements include a BSc in Life Sciences, over 7 years of experience in pharma/biotech, and proficiency in regulatory guidelines. This role offers opportunities for development within a friendly team environment, with additional benefits such as a pension scheme and lunch allowance.

Qualifikationen

• Over 7 years’ medical-writing experience in pharma/biotech.
• Advanced knowledge of global regulatory guidelines.
• Excellent written and spoken English.

Aufgaben

• Lead medical-writing for full CTD submissions across multiple development programs.
• Provide guidance on regulatory requirements and data presentation.
• Independently write or review CSRs and CTD documents.
• Collaborate with cross-functional teams for alignment on presentations.
• Supervise writers and manage outsourced writing vendors.
• Drive initiatives to improve templates and authoring tools.

Kenntnisse

Medical writing

Regulatory guidelines knowledge

Data interpretation

Mentoring

Cross-functional collaboration

Ausbildung

BSc in Life Sciences or equivalent

Jobbeschreibung

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.

Responsibilities

• 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.

Qualifications

• 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

Benefits

• Friendly working atmosphere in a great team, Great Place to Work® certified
• Development opportunities within an international company
• Different benefits e.g. pension scheme, lunch allowance
• This role needs to be onsite in our Allschwil Office near Basel minimum 4 days per week

Viatris is an Equal Opportunity Employer.