Team Member

1 week ago

Mumbai, India Cipla Full time

**Division**:

- IPD**Department**:

- IPD**Employment Type**:

- Permanent**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

**Competencies/Skills**:

- Communication Skills (clarity of thought, comprehension)- Likely potential for growth- Job / Product / Technical Knowledge / Pharma domain knowledge- Presentation & Interpersonal skills (If applicable)- Managerial or People Management skills- Safety awareness (If applicable)- Relevance of Previous Experience- Comprehension, Analytical & Problem solving abilities- Productivity & Result Orientation (If applicable)- Attitude- Qualification fitment- Sales drive (If applicable)- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)**Job Location**:
Mumbai

**Shift Hours**:

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