Senior Clinical Medical Writer (Remote / Flexible)

This a Full Remote job, the offer is available from: United States, Bolivia Job Title: Senior Clinical Medical Writer (Remote / Flexible) Job Location: United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Insulet started in 2000 with an idea and a mission to reputed company 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. 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 reputed company success depends on it! 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 reputed company 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 reputed company 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 reputed company submission-level clinical documents, to be included in registration files by interpreting clinical data clearly, accurately, and concisely and reputed company 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 reputed company clinical/market developments.
• Ensure the consistency and quality of reputed company documents that are issued.
• Create and maintain regulatory documents reputed company 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.
• reputed company 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 reputed company regulations and guidance documents.
• Expertise in reputed company, reputed company 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 reputed company organizational levels and proactively escalate issues to appropriate levels of management in the organization.
• Ability to work and reputed company reputed company a fast-paced, dynamic, and continuously changing work environment.
• Solid project management and organizational skills with the reputed company 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). Additional Information The US reputed company 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 reputed company for new hire salaries for the position in the primary work location in the US. reputed company the range, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. Your reputed company 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 reputed company salary only, and do not include bonus, equity, or benefits. At reputed company reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) reputed company ( https://reputed company.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform Apply tot his job Apply To this Job