The Sr. Medical Writer resides within Clinical Research, executing on medical writing deliverables including clinical, preclinical, non-clinical toxicology, and CMC documents for global regulatory submissions, clinical protocols and study reports, investigator brochures, pediatric investigational plans, clinical trial results postings (ClinicalTrials.gov), and other key clinical and regulatory documents.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Responsible for planning, preparation, writing, reviewing, editing, formatting, and finalizing regulatory documents (Clinical, Pre-clinical, Non-clinical toxicology and CMC programs) and external publications for marketed products and compounds in development.
- Documents include, but are not limited to, global submission documents (NDAs, MAAs), clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, other regulatory submission documents (INDs, BLAs, Briefing documents, ad-hoc requests from regulatory agencies, etc.), medical information letters, abstracts, manuscripts, posters, press releases and slide presentations for internal or external use.
- Coordinate writing activities for project teams, including timelines and document review/revision responsibilities; Cross-functional collaboration with biostatistics, clinical operations, project management, medical affairs, pharmacovigilance, regulatory, quality assurance, manufacturing, and commercial.
- Perform peer review of various clinical or regulatory documents and publications.
- Participate in group initiatives in relation to document standards, continuing template development, cross-functional processes and other aspects of document management (in collaboration with publishing group).
- Participate in medical writing process development and process improvement initiatives.
- Ensure compliance, remain informed on regulations and developments in medical writing, and maintain knowledge of product areas, current trends, and current literature.
- Perform all duties in keeping with Company’s core values, policies, and applicable regulations.
- Other duties as assigned.
Experience and Skills:
- Bachelor’s degree in life sciences with 4-5 years or more direct biotechnology or pharmaceutical industry experience as a medical writer, or advanced scientific degree in life sciences (MS or PhD) with 2-3 years or more direct biotechnology or pharmaceutical industry experience as a medical writer.
- Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal or related field, preferred.
- Prior industry experience in contributing to the preparation of non-clinical and clinical protocols, study reports, IND, IB, NDA/CTD documents.
REQUIRED KNOWLEDGE AND ABILITIES:
- Excellent writing skills coupled with comprehensive knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the drug development process.
- Demonstrated record of overseeing the successful planning and implementation of all written components of global regulatory submissions.
- Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans.
- Demonstrated record of contributing to the successful planning and implementation of a publication plan; Able to manage key opinion leaders as external authors.
- Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables.
- Appropriate computer software experience (including but not limited to Prism, MS Word, Excel, PowerPoint), in particular, document management software; Experience with electronic filings.
- Manage multiple and varied programs with competing and aggressive time lines, prioritize activities, and work independently; Able to work in a quickly changing, not fully structured internal and external environment.
- Strong interpersonal and communication skills; proactive approach.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies.