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. Documents include, but are not limited to, clinical evaluation reports (CER), clinical evaluation plans (CEP), post-market clinical follow-up (PMCF) plans and reports, clinical study protocols, investigator brochures, study synopses, clinical study 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 study protocols, investigator brochures, clinical study reports, and annual reports as required by regulators.

· 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, 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:

The US base salary range for this full-time position is $78,500.00 - $117,950.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.