Senior Clinical Medical Writer (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title: Senior Clinical Medical Writer

Department: Clinical and Medical Affairs

Grade (anticipated): 7

FLSA Status: Exempt

Position Overview:

This position will be responsible for creating high quality clinical research related documents in compliance with regulatory requirements and Insulet’s internal standard operating procedure. Documents include, but are not limited to, clinical study protocols and reports, study synopses, investigator brochures, clinical evaluation plans (CEP) and report (CER), post-market clinical follow-up (PMCF) plans and reports, and other clinical related documents as requested. This role is a global role that encompasses any geography where Insulet is either in the market or needs to be.

Responsibilities:

· 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.

· Acquire knowledge of therapeutic areas, competitor devices, and current clinical/market developments.

· Ensure the consistency and quality of all documents that are issued.

· 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.

· 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.

Education and Experience:

Minimum Requirements:

· Master’s degree in life sciences and 3+ years of medical writing experience at a medical device, biotechnology or contract research organization; or BS degree with 5+ years of experience.

Preferred Skills and Competencies:

· Understanding of world-wide clinical related regulations and guidance documents.

· Expertise in MS Word, Excel and PowerPoint.

· Demonstrated analytical skills and interpretation of clinical data.

· Excellent verbal and written communication skills.

· Strong attention to detail and exceptional follow-through.

· Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.

· Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment.

· Solid project management and organizational skills with the capacity to prioritize and multi-task.

Travel Requirements:

· This position requires some travel (domestic and international) up to 10% per year.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote 

Additional Information: