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.
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
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Additional employee wellness programs
