Chetna Joshi
Manager @Apcer Life Sciences
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WORK HISTORY
Manager @Apcer Life Sciences
New Delhi, IN
Develop and maintain excellent working relationships with clients and internal/external contacts. • Provide expert medical writing services guidance to internal and external stakeholders. • Reviewing (drafting if required) of assigned medical writing documents which includes but not limited to regulatory documents such as IBs and IB Amendments, CSRs for Phase I-IV studies, narratives, protocols, ICFs, Briefing documents for NDA/MAA/BLA submissions, web synopses, CTD Modules 2.4-2.7, 4, and 5 (including ISS and ISE), label updates including product information/SmPC, PILs, and medication guides, clinical expert statements to support Type 2 Variation Filings/RFIs in accordance with Article 8(3), 10(a), 10(b), 10(c), 10(1), and 10(4)(EU submissions) etc.• Lead and guide the medical writing team to ensure that medical writing projects deliver the value expected of the engagement, including quality, compliance, budget, and timelines. • Interact with client and other stakeholders (internal and external) in order to achieve required outcomes and meet timelines.• Monitoring the work progress, ensuring timely delivery, participating in status meetings, updating project progress to the stakeholders.• Generation, review and execution of company Standard Operating Procedures (SOPs) and Work Instructions (WI).• To carry out the necessary administrative duties required for the job.• Other duties as assigned by management.Other responsibilities include: Project management. Team management. Execution of Company SOPs. Complete required training on new and revised procedures and update training file in a timely manner. To impart trainings across company, as assigned by the reporting manager. Train and mentor new employees in medical writing, as required. Compliance to project guidelines. Maintain awareness of changes to/new regulations affecting medical writing activities.
EDUCATION
Hermann Gmeiner School. Bhimtal,Nainital
Higher Secondary, Science
Kumaun University
Masters in Pharmacy, Pharmacology
SKILLS
ABOUT CHETNA JOSHI
Experienced Medical Writing Manager with a Master\'s in Pharmacology and 11+ years in the pharmaceutical industry. Proven ability to manage complex projects for NDA/MAA/BLA submissions across various therapeutic areas. Expertise in US and EU regulatory medical writing.Key Skills:Regulatory Medical Writing (IBs, Modules 2.4-2.7, 4 & 5, CTD, SmPCs, Protocols, etc.)Project & Team ManagementScientific & Clinical Data AnalysisRegulatory Compliance (US & EU)Client Relationship ManagementAdditional Experience:Registered PharmacistPrevious experience as a University LecturerLooking to leverage my expertise in medical writing and regulatory affairs to contribute to the success of a dynamic company.
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