Team Lead/Assistant Manager - Medical Writing - Regulatory Affairs - Pharma (3-5 yrs) Gurgaon/Gurugram (QA/QC & Regulatory Affairs)
ApicalGo Consultancy
Gurgaon, India
7d ago
source :

Job purpose

To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines

Duties and 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
  • Perform science review of aggregate reports produced by PV Associates
  • Ensure that document output and processes comply with client specifications, templates and styles guidelines
  • 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 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 and Abilities :

  • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
  • Strong project management skills
  • Excellent interpersonal skills including problem solving
  • Strong negotiation skills
  • Excellent oral and written communication skills with strong presentation skills
  • Significant knowledge of global, regional, national and other document development guidelines
  • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications etc.
  • Great judgment and decision-making skills
  • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
  • Ability and desire to work in a team-oriented environment.
  • Excellent written and verbal communication skills
  • Highly proficient with Microsoft Word, PowerPoint and Excel.
  • Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
  • Possesses a collaborative, results-driven style.
  • Ability to work under pressure and provide quality outputs within tight timelines
  • Other requirements :

    As may be required from time to time - the incumbent may be required to working slots catering to different time zones

    Reports to : Director Pharmacovigilance

    ref :

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