Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies for ophthalmic diseases. AGTC is aggressively expanding and seeks a full-time Medical Writer
- The Medical Writer will report directly to the Clinical Trial Manager.
Job responsibilities will include, but are not limited to, the following.
- Oversee document preparation activities.
- Build and maintain knowledge base to improve the overall medical content of documents.
- Write and/or review reports and regulatory submission documents, protocols, amendments, review statistical analysis plans and ensure appropriate incorporation into reports.
- Write and/or review submissions to peer-reviewed journals, scientific meetings and presentations
- Drive the clinical study report writing process by conducting or ensuring the following activities have been accomplished:
- Identify report contributors and their responsibilities.
- Develop and maintain timelines.
- Ensure that all possible report activities are completed prior to database lock.
- Review primary statistical output and participate in results review meetings.
- Lead discussions on report finalization.
- Ensure Quality Control review of protocols, protocol amendments, Clinical Trial Reports, Investigator Brochures and regulatory submission documents.
- Work effectively with other staff in Clinical Operations (e.g. Clinical Trial Management, Clinical Research Management, Biostatistics, Data Management, and Clinical Monitoring) in team situations.
The successful candidate will meet the following requirements.
- Master’s degree in science or writing discipline with three to five years medical writing experience with thorough understanding of FDA and ICH guidelines.
- Demonstrated strong writing skills as evidenced by good quality writing in publications in peer-reviewed journals.
- Knowledge of statistics and their application to the interpretation and presentation of clinical data.
AGTC offers competitive compensation commensurate with education and experience. AGTC is an EOE and maintains a drug-free workplace. Please click "Apply" or send CV or resume to:
Applied Genetic Technologies Corporation
14193 NW 119th Terrace, Suite #10
Alachua, FL 32615