Principal Medical Writer

At Sobi, we are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. We are looking for a Principal Medical Writer to join our team in San Diego, CA. As a Principal Medical Writer, you will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission packages and clinical programs, to facilitate regulatory assessment, and to achieve a product label that fulfills commercial needs.

Requirements

• Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise, complete, credible and compelling scientific content aligned with the objective of the regulatory document.
• Assume primary responsibility for preparation of key clinical and 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.

Benefits

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment