Principal Medical Writer
Principal Medical Writer
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1 Vacancy
Job Description
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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.
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
In this role a typical day will include:
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.
What Youll Bring to Alcon:
Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs)
The ability to fluently read write understand and communicate in English
5 Years of Relevant Experience
How You Can Thrive at Alcon:
Join Alcons 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!
Travel Requirements: 5-10%
Relocation assistance: Yes
Sponsorship available: No
Alcon Careers
See your impact at Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY
Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.
Required Experience:
Staff IC
Employment Type
Full-Time
