The Forest Research Institute (FRI)—a wholly-owned subsidiary of Forest Laboratories, Inc.—drives the scientific research and development behind Forest’s top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institute’s highly skilled professionals enable Forest to license compounds at virtually any stage—from preclinical development to products that are ready for FDA review—and then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forest’s more than 5,000 employees—including the 900 individuals within our Research Institute—contributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest. Our Commack, NY office has an exciting opportunity available in CMC & Technical Documentation for a Technical Writer:
Description of Duties and Responsibilities:
• Prepare, coordinate and manage the process of assembling and submitting the chemistry, manufacturing and control (CMC) documents for regulatory submissions. This includes documents and information required for US and ex-US marketing and investigational applications,
• Develop and maintain a strong working knowledge of CDER guidelines and the application of these guidelines to the CMC portion of regulatory submissions
• Coordinate activities and provide guidance for internal functional groups to ensure acceptance and fileability of documents
• Interact with scientists and technical staff in the functional departments of Research and Development Group Departments in an informative and collaborative fashion which supports pharmaceutical development and regulatory filings
• Provide oral and written reports as necessary to R & D management
• Provide benefit/risk assessments to R & D management
Forest offers generous compensation packages; comprehensive training programs; stock options, profit sharing and 401(k) company match; excellent benefits packages; and a supportive work environment that thrives on teamwork and a commitment to excellence.
Committed to continuing diversity at work.
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Please apply directly to our company website through the following link:
http://www.frx.com/careers/job_description.aspx?number=98087
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