Job
Description
As a Team Lead in Medical Writing for Drug Safety & Regulatory Affairs, your role involves planning and managing medical writing activities for Regulatory and Pharmacovigilance Verticals. Your responsibilities will include: - Providing high-quality medical and scientific writing services, from coordinating literature search to delivering final drafts to internal and external clients. - Offering technical consultation and advice on strategy, regulations, and industry best practices. - Demonstrating expertise in subject matter and therapeutic areas. - Efficiently managing medical writing projects to ensure timely delivery of quality products. - Collaborating with internal and external stakeholders. - Writing various reports such as CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, and Aggregate Reports. - Managing Aggregate Reports by collecting, analyzing, authoring, and developing reports like PSUR/PBRER/PADER. - Reviewing aggregate reports produced by PV Associates. - Ensuring compliance with client specifications, templates, and style guidelines. - Developing Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS). - Conducting detailed searches on regulatory agency websites for safety alerts. - Mentoring Associates, developing training plans, and enhancing the skills of personnel. Your qualifications should include: - A Master's degree in Pharmacology, Pharmacy, or Medicine. An advanced degree is preferred. - Previous experience in the pharmaceutical/CRO industry. - Additional qualifications in medical writing (AMWA, EMWA, RAC) are advantageous. You should possess the following knowledge, skills, and abilities: - Excellent data interpretation and medical writing skills. - Strong project management, interpersonal, negotiation, and communication skills. - Knowledge of global, regional, and national document development guidelines. - Proficiency in Microsoft Word, PowerPoint, Excel, and document management systems. - Ability to work in a team-oriented environment and deliver quality outputs under pressure and tight timelines. This job requires someone with a collaborative, results-driven approach who can evaluate information systematically and communicate results effectively. As a Team Lead in Medical Writing for Drug Safety & Regulatory Affairs, your role involves planning and managing medical writing activities for Regulatory and Pharmacovigilance Verticals. Your responsibilities will include: - Providing high-quality medical and scientific writing services, from coordinating literature search to delivering final drafts to internal and external clients. - Offering technical consultation and advice on strategy, regulations, and industry best practices. - Demonstrating expertise in subject matter and therapeutic areas. - Efficiently managing medical writing projects to ensure timely delivery of quality products. - Collaborating with internal and external stakeholders. - Writing various reports such as CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, and Aggregate Reports. - Managing Aggregate Reports by collecting, analyzing, authoring, and developing reports like PSUR/PBRER/PADER. - Reviewing aggregate reports produced by PV Associates. - Ensuring compliance with client specifications, templates, and style guidelines. - Developing Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS). - Conducting detailed searches on regulatory agency websites for safety alerts. - Mentoring Associates, developing training plans, and enhancing the skills of personnel. Your qualifications should include: - A Master's degree in Pharmacology, Pharmacy, or Medicine. An advanced degree is preferred. - Previous experience in the pharmaceutical/CRO industry. - Additional qualifications in medical writing (AMWA, EMWA, RAC) are advantageous. You should possess the following knowledge, skills, and abilities: - Excellent data interpretation and medical writing skills. - Strong project management, interpersonal, negotiation, and communication skills. - Knowledge of global, regional, and national document development guidelines. - Proficiency in Microsoft Word, PowerPoint, Excel, and document management systems. - Ability to work in a team-oriented environment and deliver quality outputs under pressure and tight timelines. This job requires someone with a collaborative, results-driven approach who can evaluate information systematically and communicate results effectively.
