Associate Director, Worldwide Product Labeling (Oncology) Job - United States
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Merck & 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.
- Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.
- 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.
- 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 email@example.com.
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Job: Labeling Specifications
Job Title:Assoc. Dir, Labeling
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Oncology, Medical, Manager, Law, Pharmaceutical, Healthcare, Management, Legal, Science