Merck Senior Specialist Change Control in Rahway, New Jersey
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
As part of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Change Control & Dossier Management team, the CMC Change Control specialist will be accountable for the integrated delivery of CMC submissions in alignment with program objectives by supporting the planning, preparation, and HQ release of regulatory submissions and administering associated GRACS-CMC system/process maintenance. The CMC Change Control Specialist will support progression of CMC submissions from authorization, assessment, project definition, execution and implementation by managing detailed CMC timelines and content deliverables in partnership with CMC product teams.
The incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC dossier structure with demonstrated ability to work with cross-functional project teams. 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 assigned activities.
Operates as a member of the CMC Product team to, provide project management services for development and maintenance of timelines and collection of CMC deliverables related to preparation of Chemistry, Manufacturing, and Controls (CMC) information for new product registrations or post-approval changes including annual reports, registration renewals, supplements, variations, commitments, tender bids and responses.
Lead the planning and creation of a detailed project plan in GRACS planning tool for CMC submissions with input from identified stakeholders and the CMC Product Lead. Manage project deliverables during all phases of submission preparation (e.g. authorization, assessment, execution and close-out). Ensure project tasks are completed against plan.
Utilizes and maintains GRACS and/or our Manufacturing and Supply Division systems to promote compliant operational execution of activities related to change control and dossier preparation (GCM, REDS, ORION, USPT, Red Compass, etc), as needed.
Lead discussions and negotiate resolution of scheduling conflicts with our Manufacturing and Supply Division and Site/International CMC stakeholders to provide visibility to project constraints
Partner with CMC scientists in collection of information to support change assessments and dossier strategy. Liaise with our Manufacturing and Supply Division and internal stakeholders to promote compliant execution of change management and CMC business processes.
Progress and track project deliverables through appropriate business processes (Manufacturing Change Control Management, Content Authoring, Health Registration Management, and Regulatory Submission Planning). Conduct all activities with an unwavering focus on regulatory conformance.
Identify, assess, communicate, actively resolve or escalate potential project challenges with the CMC Product Team and/or GRACS CMC management, as needed.
Assist in the development and continuous improvement of business processes, tools, systems, metrics and analytics under supervision of manager.
Assist with submission preparation and delivery under the direction of the CMC product lead and/or team members by 1) developing virtual document structures & metadata, 2) formatting, editing (e.g. grammar, spelling, punctuation), finalizing and uploading submission related documentation into GRACS systems/tools (REDS, USPT) 3) coordinating the flow of documents via document-sharing systems (e.g., SharePoint, REDS Workflow) to ensure version control throughout the submission generation process (writing, review, and internal approval).
Provide support for other CMC projects and activities, as required.
- Bachelor’s in a relevant discipline
- Degree in science, engineering
- At least 4 years’ experience in pharmaceutical industry in either pharmaceutical, biopharmaceutical or vaccine operations (e.g., manufacturing, process development, analytical, quality assurance).
Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.g., Documentum) and document sharing systems (e.g., Team Spaces/SharePoint).
Knowledge and experience in one or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and experience with associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)..
Knowledge and experience related to change control requirements, regulatory information and supporting business processes and systems.
Capability to effectively manage and deliver against multiple and potentially competing priorities.
Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines.
Capability to work effectively in matrix organizational structures.
Demonstrated flexibility in responding to changing priorities and adapting to unexpected events by identifying innovative ways to achieve high quality, compliant deliverables.
Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing
Familiarity with CMC related CTD structure and content
- Knowledge of change control and regulatory systems
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
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Flexible Work Arrangements:
Flex Time, Telecommuting
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R139218
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