Job title: Manager, Medical Safety Writing AGS
Company: Alcon
Job description:
- Serve as the Regional Group Lead for Medical Safety Writing team responsible for authoring safety-related regulatory documents of marketed products across technology platforms in assigned countries
- Drive management of objectives, development planning, and performance of Medical Safety Writing team to align with global initiatives where applicable
- Monitor project timelines and resourcing needs across technology platforms; escalate potential concerns to Global Medical Safety management and recommend solutions as appropriate
- Ensure high-quality safety deliverables; provide guidance to Medical Safety Writers in regards to gathering safety data, authoring concise and accurate summaries, and performing quality checks
- Oversee and/or coordinate with cross-functional subject matter experts to author post-market surveillance plans and aggregate safety reports in accordance with applicable regulations and industry guidance for EU or Rest of World
- Monitor and provide periodic summaries of key performance indicators for assigned countries to Global Medical Safety management
- Support continuous improvement initiatives to optimize operational efficiency in post-marketing surveillance activities
- Support audit/inspection questions regarding Medical Safety Writing processes and deliverables
- Establish and maintain working relationships with global and local Alcon functions to ensure the fulfillment of safety-related regulatory requirements
- May function as delegate to manage additional countries according to regulatory or business needs
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.
Expected salary:
Location: Bangalore, Karnataka
Job date: Fri, 09 Sep 2022 03:28:25 GMT
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