Clinical Coordinator Drug Product Development

Job Category: Biotech/R&D/Science Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job Summary The Clinical Pharmacy group at Wyeth BioPharma is responsible for the planning, coordination and supply of drug products for global clinical studies. Working with a wide cross-section of functions within Wyeth and external partners, the Clinical Pharmacy group plays a critical role in ensuring the timely supply of study materials to the clinical sites. Clinical Pharmacy works with clinical study teams from first-in-person studies through regulatory approval and post-marketing studies to assess the drug supply requirements for potential worldwide clinical trials. Additionally, Clinical Pharmacy initiates bulk and packaging documents necessary for the preparation of Clinical Trial Material (CTM) and works cross-functionally to ensure the timely delivery of clinical supplies. Act as a Clinical Pharmacy representative to BioPharma, Chemical and Pharmaceutical Development (CPD), Clinical Research and Development, Regulatory Affairs and others as needed. Interact with CR&D personnel at study meetings and on an individual basis with other team members to obtain information on the status of ongoing or planned trials. Provide updates to Clinical Project Team (CPT) regarding the status of clinical trial materials. Responsible for ensuring timely preparation, delivery, use, and return of clinical supplies. Working with Drug Product Development personnel, provide drug information for both clinical and marketed product to Study Teams as required. Review clinical study protocols to determine drug-packaging and delivery requirements and present Pharmacy recommendations at Study Team meetings. Prepare manufacturing/packaging orders for clinical supplies on projects based on development plans, protocols, and consultation with medical personnel. Review Worldwide Clinical Development Plans to anticipate future drug supply requirements and identify potential supply problems and assist in resolution of these problems. Responsible for the shipment of CTM to clinical sites and for ensuring adequate drug supply throughout the course of the study along with the help and collaboration of Study Teams. Interact with both external and internal Interactive Voice Recognition Software vendors to set up the study specifications and to ensure adequate drug supply at the sites. Perform subject unblindings for various analyses by Study Teams. Attend and present information regarding CTM at investigator’s meetings as requested by Study Teams. Write and review company and department SOPs and Skills Training Aids as required. Satisfactorily complete all cGMP/GLP and safety training in conformance with departmental requirements. Where applicable, perform job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements. Perform other duties as assigned. Education/Experience Requirements Years/Type of Experience: BS 8+ years; MS 6+ years; or equivalent experience Other Requirements: Excellent communication skills, collaborative, detail-oriented, organized, able to anticipate needs, team player, able to work against timelines, previous experience with forecasting a plus Relocation is available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Expected Travel Time: None Zip Code :US-MA-Andover Leading the way to a healthier world.