Associate II Medical Writer
Job Summary:
Alcon is seeking a highly motivated and detail-oriented Associate II Medical Writer to join our growing team in Bangalore, India. In this role, you will be responsible for preparing high-quality clinical and safety documents related to medical device vigilance and pharmacovigilance, ensuring compliance with global regulatory standards. This is a fantastic opportunity to contribute to a leading global eye-care company and advance your career in medical writing.
Job Summary:
The Associate II Medical Writer will play a crucial role in supporting Alcon’s safety and regulatory teams. Your primary responsibility will be the creation and review of clinical and safety documents, guaranteeing their accuracy, consistency, and adherence to both internal Standard Operating Procedures (SOPs) and international regulatory guidelines. This role demands excellent communication and writing skills, as well as practical experience in medical or safety writing. You will collaborate with cross-functional teams to ensure the highest quality documentation.
Responsibilities:
- Aggregate Report Preparation: Prepare and review aggregate safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other required safety documents.
- Safety Narrative Development: Develop comprehensive and accurate safety narratives based on clinical trial data and post-market surveillance.
- Clinical Summary Creation: Prepare clinical summaries for regulatory submissions, providing a concise overview of clinical study results.
- Literature Review and Summary: Conduct thorough literature searches and summarize findings to support safety and regulatory documentation.
- Medical Device Vigilance: Support medical device vigilance activities, including the preparation of documentation related to adverse events and product complaints, in accordance with global regulatory requirements (e.g., MDR).
- Regulatory Compliance: Ensure all documents are compliant with relevant regulatory guidelines and internal SOPs.
- Cross-Functional Collaboration: Collaborate effectively with safety operations, regulatory affairs, clinical research, and other cross-functional teams to gather information and ensure document accuracy.
- Document Management: Maintain document quality and integrity using electronic document management systems (EDMS).
Requirements:
- Experience: Minimum of 2 years of experience in at least one of the following areas:
- Medical device vigilance
- Pharmacovigilance (PV)
- Medical or safety writing
- Aggregate safety reporting and literature summaries
- Software Proficiency: Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- EDMS Experience: Experience working with electronic document management systems (EDMS).
- Communication Skills: Excellent written and verbal communication skills in English.
- Work Ethic: Ability to work effectively in a fast-paced, deadline-driven environment.
- Attention to Detail: Exceptional attention to detail and commitment to accuracy.
- Education: A Bachelor’s degree in a relevant scientific field (e.g., Pharmacy, Biology, Chemistry, or related discipline) is preferred. A Master’s degree is a plus.
Benefits:
- Global Leader: Opportunity to work with a global leader in eye-care medical devices.
- International Exposure: Exposure to international regulatory documentation and guidelines.
- Professional Development: Opportunities for professional development and continuous learning.
- Inclusive Culture: Inclusive, diverse, and supportive work culture.
- Competitive Compensation: Competitive salary and comprehensive employee benefits package.
How to Apply:
[Application Instructions – e.g., Please submit your resume and cover letter through our online portal.]