Senior Medical Writer

6 hours ago

Bengaluru, Karnataka, India Celegence Full time ₹ 10,00,000 - ₹ 12,00,000 per year

Company Description

Celegence provides services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy, helping companies navigate global regulatory requirements. With expertise across all phases of the product lifecycle, including regulatory strategy, submission management, and health authority interaction, Celegence ensures compliance and efficiency. Leveraging a global team of specialists, the company offers local regulatory insights and intelligence to support clients in their day-to-day operations. Headquartered in Chicago, IL, with offices in the U.K., Europe, and Bangalore (India), Celegence is dedicated to enabling clients to focus on delivering exceptional patient value.

Role Description

This is a full-time, on-site role for a Senior Medical Writer, located in Bengaluru (hybrid model). The Senior Medical Writer will be responsible for preparing high-quality clinical evaluation and post market surveillance (PMS) documents.

Qualifications

  • Advanced degree in Life Sciences, Medicine, Pharmacy, or a related field
  • Practical knowledge of EU MDR and MDCG guidelines
  • Proficiency in Medical Writing (literature search and review, determination of safety performance objectives and acceptance criteria, trend analysis, benefit-risk analysis)
  • Hands-on experience of reviewing documents and addressing Notified Body observations is an advantage
  • Strong Research skills and the ability to synthesize complex information
  • Excellent attention to detail, ability to meet deadlines, and strong organizational skills
  • Ability to work collaboratively with diverse stakeholders and adapt to dynamic project requirements
  • Other skills we are looking for: excellent communication, proactiveness, accountability, quality mindset, open to learning

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