Health Underwriter, Sr. jobs in Lowell, MA

Reports to: Senior Director, Medical Affairs 

Position Summary 

The Sr./Medical Writer is responsible for authoring and coordinating the review of complex clinical and scientific documents supporting the Medical Affairs, Clinical Development, Regulatory, and Clinical Operations teams. S/he supports the Fractyl DMR (Duodenal Mucosal Resurfacing) program for the treatment of metabolic diseases by authoring and providing QC to manuscripts, clinical study reports, clinical evaluation reports, safety summaries, protocols/amendments, Investigator Brochure, and other documents related to the clinical program such as support for medical affairs communications and regulatory submissions. The Sr. Medical Writer applies scientific knowledge, analytical skills, and technical writing skills to all assignments, producing high quality and timely deliverables while ensuring scientific consistency between related documents or studies in clinical programs. 

Primary Responsibilities 

• Write, review, and edit publications, clinical, and technical documents for organization, clarity, language/grammar, consistency, and scientific standards. 
• Work closely with the clinical team and develop and/or edit clinical documents, including protocols, Investigator Brochures, master Informed Consent Form and other related documents 
• Work with the regulatory team and author and/or contribute to regulatory submissions, including, but not limited to, briefing documents, safety summaries, IDE/IDE supplements, PMAs. 
• Develop and/or edit scientific/clinical documents, including medical information materials (ie. Standard response letters, etc.), manuscripts, abstracts, posters, and slide presentations. 
• Work closely with the Medical Affairs management team to review and ensure the incorporation of key communication points from the scientific communication platform and overall strategy into manuscripts, abstracts, posters, and other written communications. 
• Interpret and summarize data from biostatistical summary tables and listings into narrative text (i.e. for safety summaries or clinical study reports) with accuracy, precision, and conciseness. 
• Organize, conduct, and lead document development meetings and other discussions as necessary, including comment resolution meetings; facilitate efficient review and finalization of documents to be produced. 
• Work collaboratively with study teams on related assignments, representing medical writing. 
• Develop and manage timelines for document development. 
• Maintain familiarity with current industry practices, regulatory requirements, and guidelines that affect medical writing. 
• Identify the need for, and manage, contributions from external medical writing and scientific consultants as necessary. 
• Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training. 
• Bring a “can do” spirit to work and deliver on other responsibilities as assigned. 

Education or Certification Requirements 

• Masters degree required; PhD or PharmD preferred 

Professional Work Experience 

• 10 years of experience as a medical writer in pharmaceutical, biotech and/or medical device industry 
• Applicable experience in biotech, pharmaceutical and/or medical device industries preferred. 
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.). 

Qualifications and Skills 

• Demonstrated ability to interpret and organize clinical and scientific data. 
• Technical expertise/computer skills, specifically in Microsoft Office Suite, MS Word, PowerPoint, Adobe Acrobat, document management systems. 
• Ability to work independently or with a team delivering multiple projects successfully with high quality. 
• Working knowledge of Good Publication Practices (GPP3), and ICMJE Authorship criteria. 
• Experience in type 2 diabetes and/or metabolic disorders and/or medical devices highly preferred 
• Experience using electronic documentation management system preferred 
• Strong interpersonal and communication (written and verbal) skills. 
• Strong patient focus. 

Other Essentials and Key Success Factors 

• Successful track record of working in high-growth and dynamic organizations 
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit 
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well 
• Evidence of "hands-on" experience and expertise 
• Proven and successful track record as a team-player and collaborator in small working environments
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
• Highest levels of professionalism, confidence, personal values and ethical standards 

Travel 

This position requires up to 5% travel, as needed.  

The description and requirements outlined above are general; additional requirements may apply.