Senior Manager, Clinical Services – Medical & Regulatory Writing (Noida & Thane)
Job Summary:
Cencora is looking for an experienced Senior Manager, Clinical Services with 7-12 years of expertise in core medical and regulatory writing. The role involves authoring and reviewing Clinical Study Reports (CSRs), protocols, informed consent forms (ICFs), investigator brochures, and regulatory documents (CTD Modules 2.4, 2.5, 2.6, 2.7). Candidates with strong knowledge of ICH guidelines, literature search methodologies, and data interpretation are encouraged to apply.
Key Responsibilities:
Author, review, and manage clinical documents such as CSRs, narratives, protocols, ICFs, and investigator brochures.
Prepare and review regulatory documents as per country-specific requirements.
Create and manage CTD modules (2.4, 2.5, 2.6, 2.7).
Conduct literature searches with expertise in PICOS criteria and PRISMA statements.
Plan and collaborate on data analysis and presentations for CSRs.
Ensure compliance with ICH-E6, ICH-E3, and other regulatory guidelines.
Work with TransCelerate common trial protocol templates.
Provide accurate data interpretation and maintain high documentation quality.
Handle multiple projects while ensuring timely delivery.
Required Skills & Qualifications:
Postgraduate degree in Pharmacy (Pharmacology) or Life Sciences.
7-12 years of core medical and regulatory writing experience.
Strong understanding of ICH guidelines, clinical trial protocols, and regulatory requirements.
Proficiency in literature search, data interpretation, and report authoring.
Basic understanding of statistics and clinical data presentations.
Excellent communication and project management skills.
Attention to detail with the ability to meet tight deadlines.
Perks & Benefits:
Competitive salary and industry-standard benefits.
Opportunity to work on global clinical research and regulatory projects.
Career growth with an international pharmaceutical leader.
Collaborative and knowledge-driven work culture.
Company Description:
Cencora, through its subsidiary PharmaLex India Pvt. Ltd., is a trusted partner in pharmaceutical consulting, regulatory writing, and drug development. With a global presence, Cencora focuses on delivering innovative healthcare solutions and advancing patient safety through regulatory excellence.
Work Mode: On-site – Noida & Thane, Maharashtra, India.
Call-to-Action:
If you have expertise in medical writing, regulatory documentation, and clinical research, apply now on Cencora’s careers page to advance your career with a global healthcare leader.
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