Merck Senior Scientist, Regulatory Affairs, Vaccines- Chemistry, Manufacturing, Control in Pierre, South Dakota
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Reporting to the Director, the Senior Scientist is responsible for implementing Chemistry, Manufacturing and Control (CMC) regulatory strategies for our Company's vaccine products in accordance with global regulations and guidance's, 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 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, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects.
Lead execution of CMC documentation including investigational new drug application (IND)/clinical trial application (CTA), new drug application (NDA)/ biologics license application (BLA)/marketing authorization application (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.
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.
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.
Required 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 …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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 .
Invent. Impact. Inspire.
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Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting
1st - Day
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Number of Openings:
Requisition ID: R121520
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