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Principal Medical Writer at Sobi | Cambridge

SobiCambridge
On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Qualifications and Experience:Master’s degree or PhD in Life Sciences.8-10 years of experience in regulatory medical writing with a robust understanding of scientific and regulatory principles, along with comprehensive knowledge of regulatory writing processes. Proven experience in managing complex global regulatory and clinical writing projects, including the development of complex Clinical Study Reports (CSRs), Common Technical Documents (CTDs), Orphan Drug Designation requests (ODDs), Paediatric Investigation Plans (PIPs), briefing documents, and regulatory responses. Experience leading writing activities for significant US and/or EMA regulatory submissions, coordinating the efforts of other Medical Writers, and providing submission leadership. A clear understanding of clinical development phases, processes, and techniques from protocol design to regulatory submission and support for marketed products. Advanced knowledge of the global regulatory environment and processes, including key regulatory bodies and essential documents.

About the job

As a Principal Medical Writer at Sobi, you will leverage your expertise in communication to spearhead a strategy-oriented approach in crafting pivotal clinical and regulatory documents. Your role will be crucial in ensuring clarity, credibility, and consistency of clinical information across submission packages and clinical programs, thereby facilitating regulatory assessment and achieving product labels that meet commercial needs.

Key Responsibilities:

  • Lead an effective strategy for authoring clinical components of regulatory submissions, ensuring that the scientific content is clear, concise, complete, credible, and compelling, aligned with regulatory document objectives.
  • Take the lead in preparing essential clinical and regulatory documents, including those that support major regulatory submissions and responses to regulatory agencies/health authorities.
  • Provide leadership and project coordination to cross-functional authoring teams, ensuring timely delivery, high quality, and compliance with regulatory standards for clinical documents.
  • Collaborate with senior project staff to develop a storyboard for submissions and plan document development to optimally support the proposed prescribing information.
  • Serve as a Product Medical Writer, offering strategic medical writing expertise and support across multiple projects within a clinical development program.
  • Ensure that all documents meet high technical quality standards in accordance with in-house technical requirements.
  • Mentor and develop less experienced Medical Writers.
  • Oversee and coordinate the contributions of all Medical Writers involved in documents under your purview, including in-house consultants and Medical Writers at Contract Research Organizations (CROs).

About Sobi

At Sobi, we harness the unique talents of each individual to work collaboratively and make a significant impact. We are committed to developing innovative therapies that enhance the lives of those affected by rare diseases. Our strength lies in our dedicated team and unwavering commitment to our patients. Our mission and culture at Sobi inspire us daily, and here are additional reasons to join our team:Competitive compensation. Generous time-off policy. Opportunities to expand your horizons through attendance at prominent conferences. An emphasis on work/life balance. A collaborative, team-oriented environment. The chance to make a positive impact on the lives of patients with ultra-rare diseases in need of life-saving treatments. This role can be based in various locations across Europe, including the UK.

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