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.
Reporting to the Director, the Associate Director is responsible for implementing CMC regulatory strategies for Merck's vaccine products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Primary responsibilities include, but are not limited to:
- The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle for which responsibilities include assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the development, communication, lifecycle management, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment, and product withdrawal.
- Manage execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and continued market supply of Merck vaccine products worldwide.
- Responsible to have a working understanding of the domestic and international regulations that govern the licensure of vaccines and provides Regulatory input and support during time of governmental inspections of the site.
- Conduct all activities with an unwavering focus on compliance.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal, and negotiating skills.
Please note, relocation assistance is not provided for this position.Qualifications:
- B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or licensure of biological products; or related fields.
- The candidate must be proficient in English; additional language skills are a plus.
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 firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
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