Job
Description
Role Overview: As a Team Lead in Medical Writing for Drug Safety & Regulatory Affairs, your main responsibility will be to plan and manage medical writing activities for regulatory and pharmacovigilance verticals while ensuring compliance with relevant regulations and guidelines. You will be expected to provide high-quality medical and scientific writing, offer technical consultation and advice, manage writing projects effectively, collaborate with internal and external clients, and develop various reports such as CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, and Aggregate Reports. Key Responsibilities: - Provide high-quality medical and scientific writing, from planning and coordination of literature search to final draft delivery - Offer technical consultation and substantive advice on strategy, regulations, and best practices - Demonstrate expertise in subject matter and therapeutic areas - Manage medical writing projects to deliver quality products within agreed timelines - Collaborate with internal and external clients - Write various reports including CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, and Aggregate Reports - Collect, analyze, author, and develop aggregate reports (PSUR/PBRER/PADER) - Perform science review of aggregate reports produced by PV Associates - Ensure document output and processes comply with client specifications and guidelines - Develop Risk Management Plans (RMPs)/ Risk Evaluation & Mitigation Strategies (REMS) - Maintain awareness of regulatory guidance and medical information techniques - Support Medical safety team in reviewing and managing safety information - Update Aggregate Report Tracker and perform cases reconciliation periodically - Mentor Associates, oversee training plans, and enhance the skills of personnel - Conduct detailed searches in regulatory agency websites for safety alerts Qualifications Required: - Masters degree in Pharmacology/Pharmacy/Medicine - Advanced degree preferred - Previous experience in a relevant field (comparable to 3+ years) or equivalent combination of education and training - Experience in the pharmaceutical/CRO industry preferred - Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Additional Details of the Company: The company emphasizes the importance of strong project management skills, excellent interpersonal skills, negotiation skills, oral and written communication skills, global document development guidelines knowledge, judgment and decision-making skills, computer proficiency, teamwork, and the ability to work under pressure while meeting tight deadlines. Role Overview: As a Team Lead in Medical Writing for Drug Safety & Regulatory Affairs, your main responsibility will be to plan and manage medical writing activities for regulatory and pharmacovigilance verticals while ensuring compliance with relevant regulations and guidelines. You will be expected to provide high-quality medical and scientific writing, offer technical consultation and advice, manage writing projects effectively, collaborate with internal and external clients, and develop various reports such as CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, and Aggregate Reports. Key Responsibilities: - Provide high-quality medical and scientific writing, from planning and coordination of literature search to final draft delivery - Offer technical consultation and substantive advice on strategy, regulations, and best practices - Demonstrate expertise in subject matter and therapeutic areas - Manage medical writing projects to deliver quality products within agreed timelines - Collaborate with internal and external clients - Write various reports including CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, and Aggregate Reports - Collect, analyze, author, and develop aggregate reports (PSUR/PBRER/PADER) - Perform science review of aggregate reports produced by PV Associates - Ensure document output and processes comply with client specifications and guidelines - Develop Risk Management Plans (RMPs)/ Risk Evaluation & Mitigation Strategies (REMS) - Maintain awareness of regulatory guidance and medical information techniques - Support Medical safety team in reviewing and managing safety information - Update Aggregate Report Tracker and perform cases reconciliation periodically - Mentor Associates, oversee training plans, and enhance the skills of personnel - Conduct detailed searches in regulatory agency websites for safety alerts Qualifications Required: - Masters degree in Pharmacology/Pharmacy/Medicine - Advanced degree preferred - Previous experience in a relevant field (comparable to 3+ years) or equivalent combination of education and training - Experience in the pharmaceutical/CRO industry preferred - Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Additional Details of the Company: The company emphasizes the importance of
