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Associate Director, Worldwide Product Labeling (Oncology) Job Gwynedd United States,  


Posted on : 03 May 2017

Project Description

Associate Director, Worldwide Product Labeling (Oncology)-LAB000643DescriptionMerck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.Under the supervision of Director, Worldwide Product Labeling, labeling writer is responsible for managing labeling for new products and marketed products globally. This includes collaboration with the cross-functional labeling team to develop and maintain the Company Core Data Sheets (CCDS), US, EU and rest of world labeling, including associated patient labeling documents.Responsibilities may include, but are not limited to:- Collect and review information pertinent to the safety and efficacy of assigned marketed and new products.- Prepare and circulate labeling proposals for approval through Merck s cross-functional labeling committee.- Present proposed labeling to Merck s cross-functional labeling committee for review and approval.- Provide strategic labeling guidance to Merck s cross-functional labeling committee including staying up-to-date with labeling guidances and regulations worldwide.- Coordinate and participate in preparation of submission-ready labeling documents.- Provide project management support throughout the labeling process to ensure documents are produced in a timely manner according to internal SOPs and external regulatory requirements.- Ensure all actions taken within role follow applicable SOPs and regulations so that high quality and compliant labeling documents are maintained.- Manage and provide guidance to other labeling writers as needed.- Develop/revise labeling specific SOPs.QualificationsEducation:- Bachelor s degree in a scientific or medically-related discipline required. Master s degree preferred.Required:- Minimum of 7 years of pharmaceutical experience or relevant professional experience.- Experience leading teams, driving consensus and results.- Excellent leadership, communication (verbal and writing) and collaboration skills.Preferred:- Labeling experience (company core data sheet, US , EU) in oncology or other industry experience in oncology preferred.- Proven ability in medical writing.- Regulatory submission experience.- Process improvement and compliance/quality experience.- Detail oriented, well organized, high project management skills.Our employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.Search Firm Representatives Please Read Carefully:Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Labeling SpecificationsJob Title:Assoc. Dir, LabelingPrimary Location: NA-US-PA-Upper GwyneddOther Locations: NA-US-NJ-RahwayEmployee Status: RegularTravel: Yes, 5 % of the TimeNumber of Openings: 2Shift (if applicable): N/ACompany Trade Name:Merck Nearest Major Market: Philadelphia Job Segment: Oncology, Medical, Manager, Law, Pharmaceutical, Healthcare, Management, Legal, Science

Locations

Gwynedd, PA, US

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