Expert Medical Writer

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 lifes 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 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 heres how the Expert Medical Writer role will make an impact:

• Programlevel leadership Lead oversee and coordinate medicalwriting deliverables for full CTD submissions across multiple development programs (e.g. clinicaloverview and summary modules) ensuring scientific integrity consistency and ontime delivery.
• Scientific & strategic contribution Act as subjectmatter expert on regulatory requirements; provide guidance on datapooling 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 120day safety updates PIPs investigator brochures and other documents as needed.
• Crossfunctional 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 crossfunctional 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 were 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 medicalwriting 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

At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt fully align with every requirement we still encourage you to apply. You may just be the right candidate for this or other roles.

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 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 Viatris we offercompetitivesalaries benefitsandan inclusive environment where you can use your experiences perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Employment Type : Full-Time
Experience: years
Vacancy: 1