Expert Medical Writer

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

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realize their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

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

What we offer

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

Why Viatris?

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Equal Opportunity Employer

Viatris is an Equal Opportunity Employer. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best‑class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.