Team Lead-Medical Writing-Drug Safety & Reg Affairs

Role Overview: You will be responsible for planning and managing medical writing for Regulatory and Pharmacovigilance Verticals in compliance with applicable regulatory guidelines. Your main duties will include providing high-quality medical and scientific writing, offering technical consultation, demonstrating subject matter expertise, managing medical writing projects, collaborating with internal and external clients, and ensuring document output compliance with client specifications. Key Responsibilities: - Provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. - Offer technical consultation and substantive advice on strategy, regulations, and industry best practices. - Demonstrate subject matter and therapeutic area expertise. - Manage medical writing projects effectively to deliver quality products within agreed timelines. - Write CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports, and other reports. - Manage Aggregate Reports by collecting, analyzing, authoring, and developing reports such as PSUR/PBRER/PADER. - Perform science review of aggregate reports produced by PV Associates. - Ensure document output and processes comply with client specifications, templates, and style guidelines. - Develop Risk Management Plans (RMPs)/ Risk Evaluation & Mitigation Strategies (REMS) by collecting, analyzing, and authoring. - Attend project initiation meetings and collate project briefs. - Maintain awareness of current regulatory guidance, medical information techniques, and technology related to clinical/regulatory documentation. - Support the Medical safety team in ongoing review and management of safety information. - Maintain and update Aggregate Report Tracker and carry out cases reconciliation periodically. - Mentor Associates on job skills, oversee or develop training plans/materials, conduct training sessions, and enhance the skills of personnel. - Carry out detailed searches in regulatory agency websites for safety alerts. Qualifications Required: - Master's degree in Pharmacology, Pharmacy, or Medicine. - Advanced degree preferred. - Previous experience in a related field equivalent to 3+ years. - Experience working in the pharmaceutical/CRO industry preferred. - Additional qualifications in medical writing (AMWA, EMWA, RAC) advantageous. Additional Details of the Company: The company values excellent data interpretation and medical writing skills, strong project management skills, interpersonal skills including problem-solving, negotiation skills, and oral/written communication skills. They seek candidates with significant knowledge of global, regional, national, and other document development guidelines, in-depth knowledge in a specialty area, good judgment and decision-making skills, excellent computer skills, ability to work in a team-oriented environment, and proficiency with Microsoft Word, PowerPoint, and Excel. The ability to work under pressure and provide quality outputs within tight timelines is also highly desirable.,