ARM is proud to collaborate with a prestigious consultancy firm in the life science industry, presenting an exceptional permanent position based in Munich, Germany (relocation support offered). They are offering this on a hybrid model where they will require someone onsite at least 2-3 days per week. This role offers the unique opportunity to work closely with esteemed clients and diverse projects.

This position covers Medical Writing activities across all phases of development for small molecules, biologicals, cell based and modern targeted personalised therapies.

Responsibilities include, but are not limited to:

• Medical writing activities across all phases of development.
• 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.

Requirements:

• 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).

If you are interested in discussing this further please apply directly, or alternatively contact me on jasmine.smith@arm.co.uk or 44 23 9222 8211