Reports to: Director, Clinical Operations
The Medical Writer is responsible for authoring and coordinating the review of complex clinical and scientific documents supporting the Clinical Operations, Clinical Regulatory, and Medical Affairs teams, under the direction of Director, Clinical Operations and VP, Regulatory Affairs and Quality. S/he will support the Fractyl DMR (Duodenal Mucosal Resurfacing) program for the treatment of Type II Diabetes by authoring protocols/amendments, Investigator Brochure, safety summaries, Report of Prior Investigations (ROPI), study reports and other technical documents related to the clinical program such as support for regulatory submissions. The 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.
- Write, review, and edit clinical and technical documents for organization, clarity, language/grammar, consistency, and scientific standards.
- Work closely with the clinical team to develop and/or edit clinical documents, including protocols, ROPIs, Investigator Brochures, master Informed Consent Form and other related documents.
- Work with the regulatory team to author and/or contribute to regulatory submissions, including, but not limited to, briefing documents, safety summaries, IDE/IDE supplements, PMAs.
- Work with internal teams to develop and/or edit scientific/clinical documents, including medical information materials, manuscripts, abstracts, posters, and slide presentations.
- 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
- 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.
- Maintain electronic document/publication management system, supporting the selection and implementation of selected future systems.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Bachelor's Degree in the Life Sciences, PhD/MS degree is a plus
Professional Work Experience
- 6+ years of experience as a medical writer preparing clinical/regulatory documents in pharmaceutical, biotech and/or medical device industry
- Experience in type 2 diabetes and/or metabolic disorders and/or medical devices highly preferred
- Experience using electronic documentation management system preferred
Qualifications and Skills
- Successful track record of effective program and project management
- Technical expertise/computer skills, specifically in Microsoft Office Suite, MS Word templates, Adobe Acrobat, document management systems and concepts of structured content management
- Knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
- Strong interpersonal and communication (written and verbal) skills
- Demonstrated successful track record of identifying issues effectively and proposing solutions while seeking input from internal and external stakeholders as appropriate
Other Essentials and Key Success Factors:
- Successful track record of working in high-growth and dynamic organizations
- Strong organizational skills with the ability to effectively multi-task and prioritize
- 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
- Ability to work autonomously under minimal direction
- Proven and successful track record as a team-player and collaborator in small working environments
- 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
The description and requirements outlined above are general; additional requirements may apply.