Description
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.
Alcon is looking to hire a Medical Writer Lead to join our Medical Writing Team in Fort Worth, TX. You will be responsible for representing Clinical Writing & QC on the Clinical Trial Team and accountability for the accuracy of content crafted by the Medical Writer (specifically for IBs, FTSs, CSRs, reports and other regulatory content).
Roles and Responsibilities
- Being accountable for all aspects of medical writing for assigned clinical trials and projects, ensuring scientific rigor and quality throughout the process.
- Authoring robust FTSs, CSRs, reports, and other required regulatory documents with exceptional attention to detail.
- Managing and authoring relevant sections of Investigator's Brochures (IBs) with scientific rigor and accuracy.
- Providing timely reviews and input to clinical study documentation, including protocols, MOPs, and TFLs, to ensure quality and adherence to standards.
- Representing Clinical Writing & QC on the Clinical Trial Team, actively contributing to the successful implementation of studies of medium to high complexity.
- Independently authoring Feasibility Trial Summaries (FTSs), CSRs, and other reports, demonstrating proven expertise in medical writing.
- Leading the authoring, review, and approval of IBs, ensuring accuracy and adherence to regulatory requirements.
- Implementing effective methods and guidelines for medical writing, consistently aiming for impeccable execution.
- Training and mentoring new Medical Writers, sharing your knowledge and expertise within the Surgical or Vision Care franchise.
- Continuously improving writing skills through training programs and professional development opportunities.
Qualification and Experience
- 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.
- Travel Requirements: 5% Domestic.
- Relocation assistance: No.
- Sponsorship available: No.
Preferred Qualifications
- Senior-level Medical Writing experience, demonstrating a track record of excellence in the field.
- Proven expertise in clinical trials, showcasing your in-depth understanding of the industry and its unique challenges.