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Job DescriptionOur 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.Position Description:
Provides oversight using data to inform and plan core business activities; provides the organization visibility of its data through graphs and other data visibility tools Analyze, summarize and report out on data; partners with the business areas to decode relatable data and explain/guide in applying the data learnings
Extract and combine data from non-related regulatory systems and deliver new unseen information
Supports internal and external clients with ad-hoc data reports
Construct simple MS Excel pivot tables and MS Access tables to deliver data desktop solutions
Performs process reviews and system checks to ensure high quality and compliant global submissions Assists with monitoring key performance indicators and compliance indicators; performing trend analysis; evaluating issues for root-cause; and communicating findings to Regulatory Planning & Execution Team members.
Supports resolution of those metrics which are outside acceptable boundaries Helps to identify business process improvement opportunities, documentation updates and/or training to prevent practices which could lead to quality deviations or non-compliance events
Liaises with the Global Regulatory Affairs and Clinical Safety Quality & Compliance, our Research & Development Division Quality Assurance and other external functional areas as appropriate to support any audit or inspection activities, including CAPA resolution Accountable to ensure tracking and completion of corrective and preventative action plans stemming from inspection, audit and non-compliance investigations.
Ensure appropriate evidence to support closure has been collected, documented and reported to GRACS Quality & Compliance as necessary Supports the execution of compliance centers of excellence to ensure high-quality, compliant regulatory submissions and data.
Required Experience & Skills:Education Minimum Requirement :
Bachelor’s Degree with 3-5 years of relevant experience in Quality or Compliance preferably within a regulatory environment
MS Excel Knowledge and understanding of quality and compliance systems
Ability to lead by influence and work effectively in matrix organizational structures
Ability to communicate effectively, both verbally and written, with others across levels of the organization
Knowledge of Sigma methodology and corresponding tool sets
Ability to understand details but keep overall "big picture" view of projects and strategies Highly organized individual with keen attention to detail
Desired Experience, Education & Skills:
Regulatory Experience Spotfire or PowerBI SQL MS Access
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 .INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTSIn 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.If you need an accommodation for the application process please email us at staffingaadar@merck.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & 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.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Flex Time, Work WeekShift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R55208
