CMC Data Management Specialist
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. Position Description
Under the guidance of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Product Lead(s) the CMC Data Management Specialist will provide support to CMC Product Team to enable compliant delivery of CMC submissions through planning, preparation, and execution through management of CMC Quality Data in the Health Registration Management and MMD Change Control systems. The CMC Data Management Specialist will manage the progression of CMC Change Requests, CMC Events and Regulatory Product Information from authorization, assessment, project definition, execution and implementation by administering the CMC HRM and Change Control data in partnership with CMC product teams. The incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and Health Registration Management information. The individual will be required to gather, review, update and report routine data and CMC related information and maintain regulatory tools and databases on a routine schedule to ensure visibility to the status of regulatory activities.
Primary Activities * Support CMC scientists in collection of information to support change assessments and update regulatory tools and databases, on a routine schedule to ensure timely delivery of assigned activities. The individual is expected to follow the guidance provided by the CMC Product Lead. * Works with the CMC Product Team to update CMC deliverables related to Health Registration Management data associated with the preparation of Chemistry, Manufacturing, and Controls information for new product registrations or post-approval changes including annual reports, registration renewals, supplements, variations, tender bids and responses. * Utilizes and maintains GRACS and/or MMD systems to support compliant operational execution of activities related to change control (GCM, HRM-ORION), as needed. Conduct all activities with an unwavering focus on regulatory conformance. * Support CMC scientists in collection of Health Registration Management information to support change assessments. Liaise with MMD and internal stakeholders to support compliant execution of change management and CMC business processes. * Actively manage assigned work including a clear understanding of Health Registration Management data, dependencies and critical path * Assist in the development and continuous improvement of business processes, tools, systems, metrics and analytics under supervision of manager. * Provide support for other CMC projects and activities, as required. Qualifications
Bachelor’s degree and a minimum of 10 years’ experience in the Pharmaceutical Industry or equivalent industry with focus on Quality or Data Management
Required Experience and Skills
Knowledge and experience related to CMC regulatory change control requirements, regulatory information and supporting business processes.
Knowledge and experience with Trackwise
Capability to effectively manage and deliver against multiple and potentially competing priorities.
Demonstrated flexibility in responding to changing priorities and adapting to unexpected events by identifying innovative ways to achieve high quality, compliant deliverables.
Knowledge and understanding of Lean Six Sigma methodologies and Project Management skills; ability to work effectively in matrix organizational structures, develop appropriate solutions and follow through on implementation.
Strong written and verbal communication and time management skills
Strong developed cross-functional teamwork, collaboration, influencing and negotiating skills
Computer skills: knowledge and proficient in PowerPoint, Excel and Word
Preferred Experience and Skills
Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org. 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 EEOC GINA Supplement
Job: Regulatory Affairs - CMC
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck