What are the responsibilities and job description for the Alcon is hiring: Principal Medical Writer in Fort Worth position at Alcon?
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. The Principal Medical Writer role is pivotal in driving forward our mission of advancing eye care through development of next generation products. This position is located in Fort Worth, TX.
In this role a typical day will include :
- Contributing to the development of clinical sections of regulatory documents like briefing packets, safety updates, regulatory submission documents and responses to Health Authorities questions
- Being accountable for all MW aspects of assigned clinical trials and projects
- Writing robust FTSs, CSRs, reports, and other required regulatory documents with scientific difficulty and quality
- Managing and authoring relevant sections of any IB with scientific difficulty and quality
- Providing timely reviews and input to clinical study documentation including, but not limited to protocol, MOP, and TFLs
- Representing at least eight Clinical Trial Teams at one time in conjunction for studies of medium to high complexity.
- Being responsible for the timely review of the protocol, MOP, and TFL shells and dry runs for studies of all levels of complexity
- Being responsible for independently authoring Feasibility Trial Summaries (FTSs), CSRs, and other reports
- Owning 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)
- Implementing proven methods and standards for medical writers
- Training new medical writers for all aspects within a franchise (Surgical or Vision Care)
WHAT YOU WILL BRING TO ALCON :
PREFERRED QUALIFICATIONS :
HOW YOU CAN THRIVE AT ALCON :
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