Assoc. Director, Curriculum and Training Excellence (Global Regulatory Affairs and Clinical Safety)

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.Core Responsibilities include and are not limited to:

Develops training process and training documentation, and strategies to ensure optimal coordination and availability of this content.

Partners with other functions to define training requirements, develops training materials, and strategies to ensure optimal coordination and availability of training, in alignment with our Research & Development Division activities.

Collaborates with others within Global Regulatory Affairs and Clinical Safety (GRACS) as needed to support control of our training control through development and calculation of appropriate metrics.

Collaborates wit hour Research & Development Division QA to maintain GRACS training records in Quality Management System

Participates in or leads cross-functional teams to improve training and curriculum development business process.

Participate in GRACS process owner network, with a specific focus on identifying and satisfying needs/impacts to GRACS curriculum.

Develops/maintains mailboxes, surveys or other means of collecting feedback and identifying training needs.

Collaborates with training leads across our Research & Development Division to ensure GRACS is appropriately engaged and informed of relevant training requirements (e,.g, Partners with Global Clinical Development Triage Steward to identify appropriate GRACS experts to participate in Global Clinical Development assessments)

Partners with GRACS functional area training leads and L&D to ensure active maintenance of myLearning curriculum

Education:

BS/BA or MS in health-related, life science or analytical related field.

Minimum of eleven (11) years (with BS/BA) or eight (8) years (with MS) of relevant experience in curriculum and training development, including field or headquarters scientific and/or operational roles.

Minimum of four (4) years experience leading cross-functional teams and projects.

Knowledge and understanding of regulatory and safety organizations and processes, including related standards, compliance requirements and documents.

Required Skills:

Demonstrated teamwork and leadership skills across organizational levels, including conflict resolution expertise and discretion.

Ability to embrace change/improvement and to influence others to this mindset.

Knowledge of document management systems, version control, document stewardship.

Advanced project management and organizational skills as applicable to the management of multi-functional global projects.

Excellent oral and written communications skills, including global communications.

Process improvement mindset. Knowledge of process improvement methodologies as applicable to the pharmaceutical development processes, such as Six Sigma, Lean.

Demonstrated ability to analyze, interpret and solve complex problems.

Ability to think strategically and objectively.

Business acumen.

Strong ability to collaborate effectively across all levels of an organization, and across both headquarters and country roles.

Preferred:

Knowledge of GRACS organization, roles and responsibilities.

Project Management Professions or Certified Project Management

Green or Black Belt certification in Lean/Six Sigma.

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.US and Puerto Rico Residents OnlyIf 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:Travel Requirements:10%Flexible Work Arrangements:Remote Work, Work WeekShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R56543