Clinical Medical Writer Lead

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking to hire a Clinical Medical Writer Lead who can work either remotely or in Fort Worth, TX to upcoming pharmaceutical product studies including but not limited all phases of pharmaceutical development and ISS/ISE. Responsibilities: • 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 Feasibility Trial Summaries (FTSs), 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, FTSs, 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. • Notices trends and patterns in medical writing and initiates training programs / communications / steps to improve writing skills • Accountable for all clinical writing aspects of assigned clinical trials and projects • Authors robust FTSs, CSRs, reports, lay summaries, and other required regulatory documents with scientific rigor and quality • Manages and author relevant sections of any IB with scientific rigor and quality • Trial documentation completed with quality and timeliness Key Requirements/Minimum 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 Work hours: M-F, standard Travel Requirements: 0-5% Relocation assistance: no Sponsorship available: no #LI-DNI 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 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.