Job Summary
Our innovative and growing company is looking to fill the role of Medical Writer.
Responsibilities:
- Collaborates with Clinical biometrics, Clinical operations, Clinical science, Translational medicine, Regulatory Affairs, and other departments as required, on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, Investigators Brochures, and presentation materials.
- Assisting with development and updating of templates for Investigator’s Brochures and other regulatory documents.
- Preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs and their supportive appendices (or section of these) by the incorporation of texts, graphs, charts, tables, statistical analyses, in a clear and accurate manner consistent with the target audience and regulatory requirements.
- Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions.
- Own responsibility for all background preparations, literature searches, preparation of tables and graphs and interpretation of all health policy for assigned communications.
- Manages all aspects of the medical writing processes for document development including, quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control, and coordinating final reviews and approval.
- Interpret statistical and clinical data with appropriate guidance/directions from teams and management.
Qualifications:
- Minimum degree in Life Sciences (RN, Pharm and other equivalent).
- 3-5 years of experience in a technical and/or scientific writing position in the life of sciences or health care economic fields.
- Familiarity with medical terminology and clinical trial design (theoretical knowledge is sufficient).
- Excellent time and project management skills, team working skills.
