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1 - 25 Results of 67
Merck & Co., Inc.
Rahway, New Jersey, United States
2 days ago

Description

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): 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

As part of the Global Regulatory Affairs & Clinical Safety (GRACS) - Post Approval CMC, the Senior Data Management Specialist will manage the progression of commercial/non-commercial manufacturing change controls from initial authorization throughout the project's lifecycle to completion. The candidate serves as the primary point of contact for the Business Process Team to develop and manage End-To-End (E2E) operational activities associated with the commercial manufacturing change controls in the Manufacturing Change Control System's and Health Registration Management System.

The candidate is expected to have prior experience in regulatory and/or quality, with an understanding of change control management, Health Registration Management (HRM) and Regulatory Information Management (RIM) Systems. 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 regulatory activities' status.The candidate will be required to utilize principles for effective project, organizational management, and business process design to facilitate meetings and resolve bottlenecks in the progress of commercial change controls.

Primary Activities, but not limited to:
  • Collaborating across Global Regulatory Affairs and Clinical Safety (GRACS) CMC functional area (site CMC, International CMC, Project Management Organization (PMO), Business Process Team etc.)and our Company's Manufacturing Division (MMD) partners to ensure commercial /non-commercial change control projects and related activities are on track per program objectives.
  • Aligning, monitoring, and reporting commercial/non-commercial change control project status
  • Applying knowledge of scientific and quality principles, regulatory requirements, change control standards, and GMP practices to optimize the workflow for the commercial change control.
  • Applying principles of project and organizational management to plan and perform appropriate work during each phase of the business process.
  • Identifying opportunities for innovative improvements to enhance communication, planning, organization, and daily operations to ensure timely tasks delivery.
  • Applying quality, Change Control, HRM, and RIM systems knowledge to support daily operational needs.
  • Collaborating with Business Process Leads to develop and deliver IT enabled solutions for progression of change controls from authorization to completion.
  • Ensure SOP's, job aids, and work instructions are clearly written, communicated, and understood.
  • Support Business Process functional areas and collaborate with Business Process Team to ensure training, documentation, SharePoint sites are maintained and updated to meet CMC needs.
  • Demonstrating capabilities of critical thinking to understand change control dependencies and intricacies and articulating logical, pragmatic solutions.
  • Leading small cross-functional teams to meet project milestones and demonstrating leadership necessary to build and maintain high quality change control documentation.


Qualifications
  • Bachelor's degree, in a relevant discipline. Preferred: Degree in Science or Engineering.
  • Experience should be in pharmaceutical/biotechnology industry with expertise in quality, compliance, or regulatory role (e.g. manufacturing, process development, analytical, quality assurance).
  • Minimum of 5years experience.


Skills
  • Effective communication, negotiation, problem-solving, and interpersonal skills with working knowledgeof project and organization management.
  • Experience supporting and working with tools and systems used in a regulatory/compliance environment.
  • Capability to effectively manage and deliver against multiple and potentially competing priorities.
  • Demonstrate flexibility in responding to changing priorities and adapting to unexpected events by identifying innovative ways to achieve high quality, compliant deliverables.
  • Experience with Microsoft Office tools and systems.


Preferred Experience
  • Ability to perform both strategic and tactical execution when developing and growing the business process, focusing on entire end to end process execution and ability to dive deep into the details when necessary.


Preferred Location
  • West Point, PA or Rahway, NJ


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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

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

Click here to request this role's pay range.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

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

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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:

Travel Requirements:
10%

Flexible Work Arrangements:
Flex Time

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R143558

Job Information

  • Job ID: 59300777
  • Location:
    Rahway, New Jersey, United States
  • Position Title: Senior Specialist, CMC Data Management
  • Company Name: Merck & Co., Inc.
  • Job Function: Other
  • Job Type: Full-Time
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