Clinical Literature Review Lead

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Clinical Literature Review Lead, you will write and edit documents for EU-MDR across all of Alcon’s portfolio.

In this role, a typical day will include:

Medical Writing (Life Sciences) work includes:

•    Writing and editing manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication

•    Compiling, analyzing, and summarizing additional data from other sources as needed

•    Preparing literature for new products and revising existing literature

•    Writing and maintaining files on informative journal abstracts according to current or estimated future needs

•    Composing medical papers from outlines provided by doctors for presentations

In some organizations may prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel. Requires knowledge of product areas, current developments, and keeping abreast of current literature.

• Designing compliant and sustainable literature search strategies for Class I to Class III medical device based on up-to-date European regulatory requirements (EU MDR).
• Review and edit systematic literature review protocols and reports from a group of literature review specialists to ensure high quality documentation and analyses for regulatory submissions and life-cycle management.
• Participate in the review standard operating procedures for literature reviews and templates used for literature protocols and reports.
• Interact with other cross-functional teams (Risk Management, Medical Safety, and Clinical R&D) to ensure proper prioritization of projects and assign adequate resources according to agreed strategy and timelines.
• Able to generate queries about technical content on Class I to Class III ophthalmic medical devices
• Address and resolve complex stakeholder feedback related to technical and regulatory feedback, including resolving contradictory feedback
• Assist in project management of deliverables by advocating for review strategies, alignment with adjacent processes (regulatory, clinical, post market surveillance, complaints) and taking responsibility for project information flow (status of assigned activities, issues) to cross-functional teams and manager.
• Adhere to regulatory requirements and internal policies and processes.
• Ensure effective development and implementation of training and development plans as needed.

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent year of directly related experience (or high school + 13 yrs; Assoc. +9 yrs; M.S. +2 yrs; PHD +0 yrs.
• The ability to fluently read, write, understand and communicate in English
• 2 Years of Relevant Experience
• Work Hours: 40 hrs M-F
• Travel:  up to 10%
• Relocation: NO

PREFERRED QUALIFICATIONS

• Background in ophthalmic medical devices
• Strong writing and reviewing skills
• Background in systemic Literature reviews

HOW YOU CAN THRIVE:

• Collaborate with teammates to share standard processes and findings as work evolves.
• See your career like never before with focused growth and development opportunities.
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off and much more.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to 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 or veter