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Job Information

Merck Senior Specialist Change Control in Rahway, New Jersey

Job Description

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.

Primary 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.

Qualifications

Education Requirement:

  • Bachelor’s in a relevant discipline

Preferred:

  • Degree in science, engineering

Required:

  • At least 4 years’ experience in pharmaceutical industry in either pharmaceutical, biopharmaceutical or vaccine operations (e.g., manufacturing, process development, analytical, quality assurance).

Skills

  • 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

Preferred:

  • Knowledge of change control and regulatory systems

GRACSJOBS

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.

NOTICE FOR INTERNAL APPLICANTS

In 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.

Residents of Colorado

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time, Telecommuting

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R139218

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