VIATRIS INNOVATION GMBH is a global healthcare company dedicated to delivering high‑quality medicines worldwide. We are seeking an Expert Medical Writer to lead and mentor a team of writers while producing high‑impact clinical and regulatory documents for global marketing applications. Role & What You Will Be Doing
Program‑level leadership
– Lead, oversee, and coordinate medical‑writing deliverables for full CTD submissions across multiple development programs, 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 Module2 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. Vendor oversight
– 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. Competitive salary and benefits, including pension scheme and lunch allowance. Work‑life balance initiatives. Location & Work Requirements
This role is onsite in our Allschwil Office near Basel, requiring a minimum of 4 days per week. Equal Opportunity Employer
Viatris is an Equal Opportunity Employer.
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Program‑level leadership
– Lead, oversee, and coordinate medical‑writing deliverables for full CTD submissions across multiple development programs, 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 Module2 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. Vendor oversight
– 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. Competitive salary and benefits, including pension scheme and lunch allowance. Work‑life balance initiatives. Location & Work Requirements
This role is onsite in our Allschwil Office near Basel, requiring a minimum of 4 days per week. Equal Opportunity Employer
Viatris is an Equal Opportunity Employer.
#J-18808-Ljbffr
Kontaktdaten:
1100 Mylan Pharmaceuticals Inc. Recruiting-Team
