Expert Medical Writer

## Expert Medical WriterSolicitarlocations:

Allschwil-Officetime type:

Tiempo completoposted on:

Publicado hoyjob requisition id:

R5670734VIATRIS INNOVATION GMBHViatris es una empresa sanitaria global en una posición única para tender puentes a la tradicional brecha entre genéricos y marcas, combinando lo mejor de ambos para abordar de forma más holística las necesidades sanitarias a nivel global. Con la misión de empoderar a personas de todo el mundo para vivir más saludables en cada etapa de la vida, ofrecemos acceso a gran escala, suministrando actualmente medicamentos de alta calidad a aproximadamente 1.000 millones de pacientes en todo el mundo cada año y abarcando todos los momentos de la vida, desde el nacimiento hasta el final de la vida, desde condiciones agudas hasta enfermedades crónicas.

Hemos sido incluidos en varias listas de premios que demuestran el impacto que estamos generando.

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 weekAt Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t 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 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-responsibilityEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias.

Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.
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