Principal Medical Writer

hace 1 semana

Madrid, España Sobi A tiempo completo

**Company Description**
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

We are looking for an experienced Medical Writer. The role is a permanent position reporting to the Head of Medical Writing. The Principal Medical Writer will provide expert leadership, strategic thinking and communication skills and expertise in the preparation of clinical regulatory documents throughout drug development, post-marketing and life-cycle management.
- Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise and complete scientific content aligned with the objective of the regulatory document
- Assume primary responsibility for preparation of key clinical regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities
- Provide leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents
- Liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information
- Assume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development program
- Ensure high technical quality of the documents in compliance with in-house technical requirements
- Coach and develop less experienced Medical Writers
- Oversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CRO

**Qualifications**
- Life Science Master´s degree or PhD
- A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes
- Experience in leading complex global regulatory and clinical writing projects, such as complex CTDs, ODDs, PIPs, briefing documents and regulatory responses
- Experience as lead author for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers assisting on documents under your responsibility
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
- Advanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements)

**Additional Information

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