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Job Details


Merck & Co, Inc

NDS Post-Marketing Compound Leader and Program Coordinator ( MERCUSR182493ENUS)

Sales and Marketing

Marketing Coordinator

Yearly

No

West Point, Pennsylvania, United States

Job Description

New hires in Non-Field based roles in the U.S. & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, non-office-based roles who routinely collaborate with external stakeholders such as employees in customer facing commercial or research-based roles will be required, subject to applicable law, to be fully vaccinated as a condition of employment.

As an Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group, the incumbent will be responsible for partnering with Therapeutic Area Leaders (TALs) and Program Discovery and Development (PDD) leadership to support the lifecycle management of marketed compounds (Post-Marketing Compound Leader). Additionally, the incumbent will be responsible for partnering with Discovery Program Leaders (Discovery Team Reps), Compound Leaders (Early Development and Product Development Team Reps), and Therapeutic Area Leaders to support the scientific, technical, and operational aspects of drug development in NDS (Program Coordinator). The successful candidate will work cross-functionally in a highly matrixed organization to ensure successful and efficient coordination of nonclinical safety data in support of Merck Research Labs (MRL) discovery, development, and post-marketing programs.

Primary responsibilities include:

  • Providing NDS support for maintenance of regulatory packages/documentation including, but not limited, to Product Safety Update Reports (PSURs), renewals, supplemental filings, labelling updates and responses to inquiries from Regulatory Agencies.

  • Evaluating and communication of potential safety issues identified in the available published literature for numerous Merck products across the portfolio

  • Requesting studies and providing compound and study design information in the NDS study scheduling system.

  • Interfacing with Operations - Project Planning (NDS) and impacted functional areas on changes in study designs or timelines.

  • Interacting with Central Pharmacy (NDS) and other areas in Preclinical Development (PCD) and Discovery on drug supply, allocation or materials, formulation, and stability matters.

  • Determining drug requirements for NDS studies.

  • Tracking regulatory agency comments and resolutions.

  • Providing monthly tracking in a pipeline management tool for the status, issues, and resolution plans on all active programs.

  • Ensuring that program issues are appropriately escalated to NDS management.

  • Standardizing and optimizing procedures and processes involved in compound development within NDS and across PCD.

Education Minimum Requirement:

BS or BA or equivalent in biological, chemical or pharmaceutical, toxicology or regulatory sciences required.

Preferred: MA/MS/MBA equivalent in fields above.

Required Experience and Skills:

  • At least 5 years of demonstrated experience in nonclinical drug safety, toxicology, or similar function.

  • Understanding of drug discovery and development process particularly as it relates to nonclinical aspects of discovery and development as well as familiarity with the broad scope of safety assessment studies that support drug discovery, clinical development, and marketing approval.

  • Evidence of strong cross-functional collaborative skills and ability to thrive in a matrixed work environment.

  • Excellent communication skills, including experience with meeting facilitation and presentations.

  • Ability to execute independent projects, and balance activities for multiple projects simultaneously.

  • Capacity and flexibility to immediately and independently take on new urgent assignments, balance other work accordingly, and interface with other areas as needed to accomplish the assignment.

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., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

No Travel Required

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R182493