Job Title : Senior Clinical Medical Writer
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 procedures. Documents include, but are not limited to, clinical study protocols and reports, study synopses, investigator brochures, clinical evaluation plans (CEP) and reports (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.
- 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.
Education and Experience
Minimum Requirements include :
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 experiencePreferred 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 up to 10% of the time (domestic and international).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 :
Compensation & Benefits :
For U.S.-based positions only, the annual base salary range for this role is $101,925.00 - $152,887.50
This position may also be eligible for incentive compensation.
We offer a comprehensive benefits package, including :
Medical, dental, and vision insurance401(k) with company matchPaid time off (PTO)And additional employee wellness programsApplication Details :
This job posting will remain open until the position is filled.
To apply, please visit the Insulet Careers site and submit your application online.
Actual pay depends on skills, experience, and education.
Insulet Corporation (NASDAQ : PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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