Alcon, a global leader in eye care, is seeking an Associate I – Medical Writer to join its team in Bangalore. This role involves authoring and managing regulatory safety documents, ensuring compliance with global standards, and collaborating with cross-functional teams.
Key Responsibilities:
✔ Act as the primary author for regulatory safety documents, including:
- Post-market surveillance plans
- Safety narratives
- Aggregate reports (e.g., Periodic Safety Update Reports – PSURs)
✔ Address reviewers’ comments and manage revisions with minimal supervision.
✔ Gather, analyze, and interpret safety data for assigned projects.
✔ Collaborate with subject matter experts to ensure accuracy, quality, and regulatory compliance.
✔ Maintain up-to-date knowledge of global regulatory requirements for medical writing.
Qualifications & Skills Required
Education & Experience:
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Medicine, or related field.
- 1-3 years of experience in medical writing, regulatory affairs, or pharmacovigilance.
- Prior experience in aggregate safety reports (PSURs, PBRERs, DSURs) is a plus.
- Familiarity with ICH-GCP, GVP, and other regulatory guidelines.
Skills & Competencies:
- Strong scientific writing and data interpretation skills.
- Ability to work independently and meet tight deadlines.
- Excellent communication and collaboration skills.
- Proficiency in Microsoft Office and document management systems.
About Alcon
Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With a 70+ year legacy, Alcon develops innovative surgical and vision care products to treat eye diseases and improve vision quality.
Why Join Alcon?
✅ Work with a globally recognized eye care leader.
✅ Innovative & inclusive work environment.
✅ Career growth opportunities in regulatory writing & pharmacovigilance.