Principal Medical Writer
Sobi
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.
Job Description
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
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
Additional Information
London
Wed, 06 Mar 2024 23:35:05 GMT
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