Principal Medical Writer

About Alcon

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Research & Development function, a team that innovates boldly and delivers new products and services to help revolutionize the eye care industry, advance optimal patient outcomes and help people see brilliantly.

Principal Medical Writer Responsibilities

For the Principal Medical Writer position, you will be able to work remotely and you will be accountable for all clinical writing aspects of assigned clinical trials and projects, author robust reports, summaries, and regulatory documents with scientific rigor and quality, including device and/or pharma CSRs, plain language and other summaries, and submission modules (i.e., NDA), manage and author relevant sections of any IB with scientific rigor and quality and ensure that all writing is completed with quality and timeliness.

Each Medical Writer Lead will represent Clinical Writing on up to 8 CTTs at one time for studies of medium to high complexity.

• Responsible for the timely review of the protocol, MOP, and TFL shells and dry runs for studies of all levels of complexity
• Responsible for the timely delivery of IBs (regardless of complexity)
• Responsible for independently authoring various summaries, CSRs, and other reports
• Manages the authoring, review, and approval of IBs (authoring sections, as appropriate)
• Accountable for the accuracy of content created by the Medical Writer (specifically for IBs, summaries, CSRs, reports and other regulatory content)
• Responsible for implementation of best practices and standards for Clinical Writing
• Trains new Medical Writers for all aspects within a franchise
• Provides critical feedback on templates as they relate to medical writing best practices and consistency
• Notices trends and patterns in medical writing and initiates training program/communication/steps to improve input quality
• For outsourced studies/deliverables, defines clinical outsourcing specifications and scope of work for clinical trial vendors. Oversees conduct of tasks.
• Contributes to the development of clinical sections of regulatory documents like briefing packets, safety updates, regulatory submission documents, and responses to Health Authorities questions.
• Writing and editing of pre-clinical and/or clinical reports.
• Ensures timely development and completion of investigator brochure, clinical reports, summary documents, lay summaries, package inserts and other documents for submission to regulatory agencies.
• Provides recommendations for the development of formats and guidelines for documentation.

Qualifications

• Bachelor’s Degree or Equivalent years 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
• 5 Years of Relevant Experience

How You Can Thrive at Alcon

• 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!

Additional Information

• Employment Type: Full time
• Travel Requirements: 5-10%
• Relocation assistance: Yes
• Sponsorship available: No

Alcon Careers

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