Merck Global Regulatory Affairs and Clinical Safety: Vaccines CMC in Lansdale, Pennsylvania
Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The Chemistry, Manufacturing and Control (CMC) Project Lead is accountable for the delivery of all regulatory milestones for less complex projects through the product life cycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
Lead the development, communication, life cycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects.
Lead execution of CMC documentation including Investigational New Drug application/Clinical Trial Application, New Drug Application/Biologics Licensing Agreement/Marketing Authorization Application, 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.
Education Minimum Requirements:
- B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Biochemistry, or Pharmacy.
Required Experience and Skills:
At least five (5) years of relevant experience, including biological/vaccine research; manufacturing, testing, or licensure of biological/vaccine products; or related fields.
The candidate must be proficient in English; additional language skills are a plus.
Preferred Experience and Skills :
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).
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.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R45896
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