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).

