Aurigene Pharmaceutical Hiring Medical Writers at Bangalore Location
POSITION – MEDICAL WRITER
Educational Qualification : MSC / M Pharm, PHD Candidates
EXPERIENCE : 3-5 Years Of Experience As A Medical Writer In A Clinical Research Organization Or A Pharmaceutical Company OR A Scientific Publication Organization. Experience In Regulatory Medical writing such As Clinical Study Protocols, Clinical Study Reports And Investigator’s Brochures for Early And Late-phase Clinical Trials.
- To write, review, and edit clinical regulatory documents such as clinical study protocols, clinical study reports, Investigator’s Brochures, and other documents as required for submissions.
- Independent preparation of clinical study protocols and clinical study reports including interpretation of clinical and pharmacokinetic data and statistical results.
- To prepare and review patient safety narratives.
- To manage 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.
- To develop, edit and review regulatory documents within agreed timelines that have high quality scientific content, organization, clarity, accuracy, format and consistency.
- Comply with established company policies and procedures, and regulatory guidelines applicable to Clinical development.
- Should have a broad awareness of developments in the relevant therapeutic areas & ensure scientific and clinical relevance of written materials in specific project activities.
Application Process : Interested Candidates may Share Their Resume To email@example.com