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.
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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.
#J-18808-Ljbffr
