Global Submissions Medical Writer Lead

1100 Mylan Pharmaceuticals Inc.; Allschwil; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Lunch allowance

Pension scheme

Zusammenfassung

VIATRIS INNOVATION GMBH seeks an Expert Medical Writer to lead strategic scientific writing for global regulatory submissions. You'll coordinate cross-functional teams, mentor junior writers, and drive process improvements with a focus on new technologies, based onsite in Allschwil near Basel.

Ideal candidates bring 7+ years of pharma/biotech medical-writing experience, strong regulatory knowledge, and excellent English communication.

Qualifikationen

• BSc in Life Sciences or equivalent.
• 7+ years medical-writing experience in pharma/biotech with global submissions.
• Advanced knowledge of global regulatory guidelines.
• Ability to interpret and present complex scientific data clearly.
• Excellent written & spoken English.
• Ability to set priorities, manage risk, and meet timelines.
• Track record of mentoring writers and influencing senior stakeholders.

Aufgaben

• Lead, oversee, and coordinate medical-writing deliverables for full CTD submissions across multiple development programs.
• Act as subject-matter expert on regulatory requirements; provide guidance on data-pooling and document positioning.
• Independently write or critically review CSRs, CTD Module 2 documents, responses to agency questions, briefing packages, and other documents.
• Partner with Clinical, Biostatistics, Clinical Pharmacology, Drug Safety, CMC, Regulatory Affairs, and other stakeholders.
• Supervise Senior/Regulatory Writers and Disclosure managers; manage outsourced writing vendors.

Kenntnisse

Medical writing

Leadership

Regulatory knowledge

English proficiency

Ausbildung

BSc in Life Sciences or equivalent

Jobbeschreibung

VIATRIS INNOVATION GMBH seeks an Expert Medical Writer to lead strategic scientific writing for global regulatory submissions. You'll coordinate cross-functional teams, mentor junior writers, and drive process improvements with a focus on new technologies, based onsite in Allschwil near Basel.

Ideal candidates bring 7+ years of pharma/biotech medical-writing experience, strong regulatory knowledge, and excellent English communication.