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Opportunity for Ph.D, M.Pharm, MSc as Team Member @ Cipla

Opportunity for Ph.D, M.Pharm, MSc as Team Member @ Cipla

Post : Team Member – Regulatory Medical Writing (42792)

Job Description
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.

Candidate Profile
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

Additional Information
Job ID : 42792
Qualification : B. Pharm/ M. Pharm/ PhD (Pharmacology)/ MSc
Location : Vikhroli, Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Medical Writing
End Date : 25th November, 2020

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Allowed Type(s): .pdf, .doc, .docx

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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