Senior Regulatory Medical Writer

CK Group are recruiting for a Senior Medical Writer to be based in the Munich area, working on a hybrid basis two to three days per week in a permanent role. The role will be focusing on medical writing activities across all phases of development for small molecules, biologicals, cell based and modern targeted/personalized therapies.

 

Tasks & Responsibilities:

- Medical writing activities across all phases of development for small molecules, biologicals, cell based and modern targeted/personalized therapies.

- Compilation and writing of documents required during clinical development stage, including e.g., Clinical study protocols, Investigator Brochures, Clinical study reports, and publications.

- Authoring a broad variety of different high-quality regulatory documents required for marketing application dossiers, including non-clinical and clinical summaries, clinical overviews, risk management plans, product information documents, and responses to agency questions.

- Provision of strategic gap analyses of draft regulatory documents and clinical data packages and conduct of critical literature searches to support and strengthen the messaging.

- Documentation to support agency meetings (briefing books, presentations, meeting minutes).

- Preparation of documents aimed at accelerating drug development and approval such as Fast Track, Breakthrough Designation and PRIME applications.

- Generating further documents as applicable in the particular projects, as e.g. Orphan Drug Applications, Diversity Plans, and Paediatric Investigation Plans.

- Close interaction in cross-functional project teams, both internally as well as with the clients.

 

To succeed in this role you will need to have an Advanced degree in life sciences, medicine or veterinary medicine, preferrably up to PhD/Doctorate level.

- Longstanding experience in medical writing on wide range of regulatory documents

- Understanding of EMA, FDA and ICH regulations and guidelines

- Ability to work independently, analyse and summarise data (clinical, non-clinical, quality)

- Ability to manage multiple tasks simultaneously under time constraints

- Excellent communication skills in English

- Strong knowledge of Microsoft Office and graphical software 

 

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 104627 in all correspondence.