- 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 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