Sr. Technical Writer

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:Primary Role Prepare quality (CMC) sections of regulatory submissions in collaboration with research, product development, QA, QC, and manufacturing teams. Responsibilites With minimal supervision, manage preperation of CMC sections of regulatory submissions form investigational and marketed products, and ensure timely delivery of high quality regulatory submissions that are consistent with US/CAN/EU regulations and ICH guidelines for global submissions Advise and coordinate development of CMC sections of regulatory submissions through cross-fuctional teams from research, product development, manufacturing, and QA/QC Develop and maintain CMC shell documents for clinical trail applications and marketing applications May be involoved in preparing non-clinical sections of regulatory submissions Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: Education and Experience Requirements B.S./M.S. in biochemistry, chemistry, biology, or related pharmaceutical field. Advanced degree is desirable Six to eight years experience in pharmaceutical or biotech product development with ideally two to four years experience writing CMC regulatory submissions A strong biologics background preferred Key Skills and Competencies Strong written and verbal communication skills and proficiency in MS Word is required Proven ability to analyze and organize information logically Fundemental knowledge of ICH, FDA, and EU guidelines relevant to CMC aspects of product developemtn Documentum experience is helpful Ability to coordinate and prioritize multiple projects in a fast-paced, deadline-driven environment Ability to work effectively and collaboratively in a team environment Apply to Shire