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Assoc. Director Global Regulatory Affairs CMC - Change Control Team Lead - Rahway, NJ #4034322


Company: Merck

Date: 10/13/2017

Category: Computer Software

City: Rahway, NJ

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.


Under the guidance of the head of the Global Regulatory Affairs CMC Change Control Team, the Associate Director will on-board and lead a team of ~5-10 staff responsible for the integrated delivery of CMC submissions in alignment with program objectives by supporting the planning, preparation, and release of regulatory submissions and administering associated Global Regulatory Affairs CMC systems and process maintenance. The team is responsible to support progression of select pre-approval or post-approval CMC submission types from authorization, regulatory impact assessment, project definition, execution and implementation by managing detailed CMC timelines and content deliverables in partnership with global CMC product teams. The incumbent will collaborate with the broader Global Regulatory Affairs organization to develop and promote use of standard processes and systems to ensure CMC dossier conformance.


The incumbent will be responsible for coaching and mentoring team members and be responsible for guiding and overseeing implementation of new systems and processes for planning, project management and dossier finalization. The incumbent will ensure successful execution of objectives, provide timely feedback to employees, and focus on the development of the employee by facilitating regular development discussions. While the primary role of the incumbent is to manage the team, the incumbent will also serve as member of CMC Product Teams for highly complex projects to execute planning, preparation of CMC components, and management of CMC timelines and content deliverables using processes and systems to balance workload within the team.


Responsibilities include but are not limited to:


  • In collaboration with Global Regulatory Affairs Operations, CMC Product Teams and CMC Business Process teams, and under direction of the head of CMC Change Control and Dossier Management:


  • Onboard a team of CMC Change Control specialists to manage CMC projects related to preparation and delivery of CMC (Chemistry, Manufacturing, and Controls) dossier content for select CMC submission types potentially including new product registrations, post-approval changes, responses to Health authority questions, regulatory commitments, tender bids, and maintenance filings including annual reports and registration renewals


  • Promote the incorporation of processes for global and regional planning of CMC dossier components in partnership with CMC staff in US headquarters and regional CMC hubs


  • Ensure GRACS and/or MMD systems and associated standardized processes are used to ensure compliant operational execution of activities related to dossier preparation and change control (e.g. Trackwise/GCM, Regulatory Content Authoring & Management (RCAM), Unified Submission Planning Toolkit (USPT), Health Registration Management (e.g. ORION), Dossier Change Control Management (DCCM), Regulatory Requirements Databases (e.g. Red Compass), etc), as needed.


  • Contribute to establishing organizational and process efficiencies for submission preparation and delivery including formatting, finalizing and uploading submission related documentation into GRACS systems/tools (RCAM, USPT).


  • Actively integrate with internal GRACS stakeholders to enable compliant execution of change control management and CMC business processes.


  • Conduct all activities with an unwavering focus on regulatory conformance.


  • Act as a change agent for the team in the establishment of new capabilities.


  • As applicable, execute planning, preparation of CMC components, and management of CMC timelines and content deliverables using processes and systems.

Education:


  • Bachelor’s degree or higher in a scientific discipline.


  • A minimum of six (6) years in the pharmaceutical and/or medical device industry with a minimum of three (3) years in CMC Regulatory Affairs

Required:


  • Strong experience in manufacturing change control, global regulatory CMC strategy development, planning and execution of submissions


  • Strong aptitude for understanding regulatory systems and processes


  • Requires strong interpersonal, influence, and negotiation skills across all levels.


  • Effective at energizing others, establishing clear goals, mentoring and coaching team members


  • Demonstrated situational leadership and creative problem solving within organizations and teams


  • Demonstrated ability to collaborate, communicate, supervise and coach across cultures, organizational levels and disciplines.


  • Ability to work effectively in matrix organizational structures


  • Ability to understand details, but keep overall "big picture" view of projects and strategies

Preferred:


  • Experience in project management methodologies (e.g. PMP, Sigma, Change Management, etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.


If you need an accommodation for the application process please email us at staffingaadar@merck.com.


Search Firm Representatives Please Read Carefully:


Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


Visa sponsorship is not available for this position.


For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf


EEOC GINA Supplement​ at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf


Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job Regulatory Affairs - CMC


Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Other Locations: NA-US-NJ-Rahway, NA-US-NJ-Kenilworth


Title: Assoc. Director Global Regulatory Affairs CMC - Change Control Team Lead


Primary Location: NA-US-PA-West Point


Requisition ID: REG003261


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