Job Description

Job purpose

To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable 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
• Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
• 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

Education & Experience

• Master’s degree in a Pharmacology/Pharmacy/Medicine with 5 years Experience
• 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

Direct reports: Nil

Location: Gurgaon