CIPLA Hiring Team Member - Regulatory Medical Writing B. Pharm/ M. Pharm/ PhD (Pharmacology)/MSc (Clinical research) Apply Now
Job Purpose
Develop and review clinical documents for regulated and
non-regulated markets ensuring regulatory compliance and thus assisting on-time
product registration and renewal
Accountabilities
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
Education Qualification
B. Pharm/ M. Pharm/ PhD (Pharmacology)/MSc (Clinical
research)
Relevant Work Experience
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
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