Merck Regulatory Affairs International (RAI) Liaison Senior Scientist- Oncology in Rahway, New Jersey
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.
The Regulatory Affairs International Headquarters (RAI-HQ) Senior Scientist position is a broad role encompassing all aspects of regulatory strategy including Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety, risk management, and labeling. He/She has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products. The Senior Scientist reports to a Director in RAI-HQ.
The Senior Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.
Specific responsibilities (with coaching and managerial oversight) include:
Create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.
Create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e. mature) products.
Occasionally review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.
Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.
Collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, MRL and across Divisions with GHH and MMD to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities.
Support for Clinical Trial Applications (CTA’s) in Phase I-III, Product, Registration and Launch (PR&L) filings, and post filing activities.
Participate in business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams
Act as the Global Regulatory Team (GRT) Lead for assigned products
May have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.
- Previous industry experience is required.Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.
- Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.
Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 4 years of relevant experience in the pharmaceutical industry. Alternatively a Master’s or other advanced degree with at least 2 years of relevant experience in pharmaceutical industry.
Must have excellent communication skills (both oral and written)
Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
Flexibility and negotiating skills are required.
Strong scientific and analytical skills.
Strong collaboration skills and partnering mindset.
Prior regulatory experience is preferred but not required.
Experience working with external partners preferred but not required.
Prior Clinical Trial Experience is preferred but not required.
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.
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.
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Requisition ID: R103080