Team Lead-Medical Writing-Drug Safety & Reg Affairs
Team Lead–Medical Writing-Drug Safety & Reg Affairs
Experience: – 5+ Years
Location: Gurgaon (On-site)
Job purpose
To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines
Roles & Responsibilities
- Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate subject matter and therapeutic area expertise.
- Effectively manage medical writing projects to deliver quality products in agreed timelines.
- Collaborate with internal and external clients,
- Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
- Management of Aggregate Reports – collecting, analyzing, Authoring and developing aggregate reports (PSUR/PBRER/PADER)
- Perform science review of aggregate reports produced by PV Associates
- Ensure that document output and processes comply with client specifications, templates and styles guidelines
- Development of Risk Management Plans (RMPs)/ Risk Evaluation & Mitigation Strategies (REMS) – data collection, analysis, Develop & Author.
- Attend project initiation meeting, collate project brief.
- Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
- Supporting Medical safety team in ongoing review and management of safety information
- Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
- Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.
Education & Experience
- Master’s degree in a Pharmacology/Pharmacy/Medicine
- Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Knowledge, Skills & Abilities
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Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
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Strong project management skills
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Excellent interpersonal skills including problem solving
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Strong negotiation skill.
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Excellent oral and written communication skills with strong presentation skills
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Significant knowledge of global, regional, national and other document development guidelines
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In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
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Great judgment and decision-making skills
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Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
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Ability and desire to work in a team-oriented environment.
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Excellent written and verbal communication skill.
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Highly proficient with Microsoft Word, PowerPoint and Excel.
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Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner.
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Possesses a collaborative, results-driven style.
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Ability to work under pressure and provide quality outputs within tight timelines