Sr. Specialist, Regulatory CMC (Medical Device & Combination Products) Job - United States
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 Sr. Specialist is responsible for implementing Medical Device and Combination Product CMC regulatory strategies for Merck's 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 Medical Device and Combination Product CMC Lead is accountable for the delivery of all regulatory milestones for less complex products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the development, communication, lifecycle management and review of the Medical Device and Combination CMC Regulatory Strategy Document for smaller-scoped projects.
- Lead execution of Medical Device and Combination CMC documentation including support of IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Conduct all activities with an unwavering focus on compliance.
- Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance, medical devices).
- Demonstrated ability to generate innovative solutions to 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, and interpersonal skills.
- 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, Biomedical Engineering or Biochemistry.
- At least two (2) years of relevant experience, including biological/pharmaceutical/ medical devices; 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.
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Visa sponsorship is not available for this position.
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Job: Regulatory Affairs - CMC
Job Title:Sr. Spclst, Regulatory Affairs-CMC
Primary Location: NA-US-NJ-Kenilworth
Other Locations: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Biochemistry, Microbiology, Medical, Regulatory Affairs, Law, Science, Healthcare, Legal