Team Member - Regulatory Medical Writing Job in Cipla Inc

DivisionIPDDepartment

Clinical R&D

Develop and review clinical documents for regulated and non-regulated markets ensuring regulatory compliance and thus assisting on-time product registration and renewal

1. Develop and review documents for clinical and bioequivalence studies to align with product strategy and registration
2. Develop and review common technical documents for regulated and non-regulated market as per country specific guidance for timely registration and renewal of dossier
3. Prepare proposals and justification of queries to different regulatory bodies by gathering literature to obtain approvals/waivers for the molecule
4. Prepare and review SOPs and templates to implement standardized systems and document framework to achieve consistent quality and uniformity in documentation
5. Prepare manuscripts/ abstracts for publication by evaluating the studies conducted by Cipla to represent Cipla globally

B. Pharm/ M. Pharm/ PhD (Pharmacology)/MSc (Clinical research)

B. Pharm with at least 3-4 years of experience in medical and regulatory writing, M. Pharm (Pharmacology), MSc (Clinical research) with at least 2-3 years of experience in medical and regulatory writing. PhD (Pharmacology) with at least 1-2 years of experience in medical and regulatory writing

Vikhroli