Sr Clinical Medical Writer (Hybrid)

This position will be responsible for creating high quality clinical research related documents in compliance with regulatory requirements and Insulet’s internal standard operating procedures. The role is a global position that encompasses any geography where Insulet is either in the market or needs to be.

Requirements

• Write documents, including complex submission-level clinical documents, to be included in registration files by interpreting clinical data clearly, accurately, and concisely and within the designated timelines.
• Author clinical documents such as clinical study protocols and reports, summary reports, study synopses, and investigator brochures.
• Create and maintain regulatory documents related to clinical data (CEP, CER, PMCF, Annual Reports, etc.) in liaison with other departments in compliance with applicable regulatory requirements.
• Acquire knowledge of therapeutic areas, competitor devices, and current clinical/market developments.
• Ensure the consistency and quality of all documents that are issued.
• Plan and execute structured literature searches and identify and analyze relevant clinical data.
• Review the literature and interpret and summarize risks, alternative therapies, and device-specific benefits. Appraise scientific literature and write clinical summaries for products.
• Perform other tasks as required.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan