Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts.
Post : Medical Writer
Desired Profile :
• MSc, M.Pharm, PhD candidates with 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.
Job Description, Key Skills and Competencies
• 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 regulatory submissions.
• To prepare clinical study protocols and clinical study reports including interpretation of clinical and pharmacokinetic data and statistical results independently.
• 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, 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.
Location : Bangalore (Office based)
Submit your candidature & updated resume to ishita_m@aurigene.com
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