Merck Hiring for Sr. Specialist, Regulatory Submission Manager at Rahway, New Jersey Full Time

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.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Regulatory Planning & Execution works closely with various stakeholders to drive the identification, planning, resourcing, execution, and management of activities to deliver high quality and timely regulatory and safety submissions. Responsibilities include independent management of all submission projects, at any level of complexity, across all submission types throughout the product lifecycle. The incumbent is expected to be skilled in project management with a demonstrated track record of leadership in a cross-functional setting.

Additionally, the incumbent may be involved in leading or supporting internal or external process improvement or strategic initiatives.

Primary Activities:

• Assemble a cross-functional team and drive the identification, planning, and execution of regulatory and safety submissions, with an end-to-end mindset

• Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant stakeholders

• Identify, assess and actively resolve or escalate, where necessary, any risks or issues that could impact the successful execution of submissions

• Actively create and manage timelines including a clear understanding of dependencies and critical path activities

• Ensure project data, including information used to maintain compliance and aid with submission planning, is accurately reported in databases

• For assigned products, works closely with the Regulatory Lead to assess the overall program and manage the sequencing of submissions as needed

• Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables

• Actively lead and/or participate in continuous improvement activities including business processes, tools, systems, metrics and analytics

• Continuously develop and improve leadership and project management skillsets, understanding of drug/vaccine/biologics/device development, and regulatory practices

Education Minimum Requirement :

• Bachelor’s Degree

Required Experience and Skills:

• Ability to lead, influence and work effectively in a matrix organization.

• Effective at establishing clear goals and assigning responsibility in a team setting

• Effective team facilitation with ability to establish collaborative team environments

• Detail-oriented with the ability to understand the “big picture” and overall strategy of projects/programs

• At least 3 years of working experience within a pharmaceutical/healthcare/consumer care industry in a project management/regulatory affairs and/or pharmacovigilance/risk management function

Preferred Experience and Skills:

• Knowledgeable in the management and successful delivery of regulatory submissions Advanced degree preferred (engineering or scientific discipline, MBA) Technically skilled in project management methodologies (e.g. PMP)

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:

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

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EEOC GINA Supplement​

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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:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R142472