Job Title:
Senior Medical Writer

Req #:
4610BR

Job Description:
Research, create and edit documents associated with clinical research for submission to global regulatory authorities, including but not limited to study protocols, interim and final clinical study reports, clinical overviews and summaries, and clinical investigator brochures. Manage medical writing projects by coordinating and facilitating document review meetings and ensuring writing projects completed within specified timelines. Provide content and editing review of draft and final documents prepared by other writers before external distribution. Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental SOPs and style guidelines. Review statistical analysis plans to assist in determining appropriateness of content/format for clinical writing. Provide training and guidance and act as a mentor to less experienced department members. Initiate and participate in departmental or interdivisional process improvement and training initiatives.

Job Duties:
Research, write and publish clinical trial interim and final reports for Vision Care, Pharmaceutical, Surgical, and Refractive studies. Prepare other clinical documents for Vision Care, Pharmaceutical, Surgical and Refractive studies in support of Regulatory submissions, i.e., clinical protocols, clinical investigator brochures, clinical overviews, and clinical summaries. Manage assigned writing projects by conducting review meetings and coordination of document finalization/approvals. Initiate and participate in departmental or interdivisional process improvement and training initiatives i.e., style guide updates, LEAN processes, medical writing template updates.

Qualifications


Education:
Bachelor's degree in Life Sciences/Health-related sciences or equivalent required. Advanced degree desired. Experience: At least 5 years medical writing experience in a contract research organization or pharmaceutical or biotechnology firm, or 3 years experience with advanced degree.

Special Skills:
Demonstrated understanding of the drug/medical device development process and a broad knowledge of requirements for FDA/Regulatory Agency submissions; extensive clinical/scientific writing skills, understanding of statistics, strong competency in MS Office and Adobe applications, excellent written and oral communication and interpersonal skills, team leadership skills. Specialized Training: Statistics and/or regulatory experience a plus.

Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes

Status Full-Time