Medical Writer

Employer
AGTC
Location
Alachua, Florida
Posted
Apr 16, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

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

Reporting Relationship:

  • The Medical Writer will report directly to the Clinical Trial Manager.

Responsibilities:

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.

Requirements:

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:

Human Resources

Applied Genetic Technologies Corporation

14193 NW 119th Terrace, Suite #10

Alachua, FL 32615