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Merck

Senior Scientist Regulatory Affairs International HQ - V&ID (Vaccines)

Rahway, NJ

Job Description

R3 Senior Scientist Job Description

The Regulatory Affairs International Headquarters (RAI-HQ) R3, Senior Scientist position is a broad role encompassing all aspects of regulatory strategy including Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety, risk management, and labeling. He/She has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products. The Senior Scientist reports to a Director in RAI-HQ.

The Senior Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.

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Specific responsibilities (with coaching and managerial oversight) include:

  • Create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.
  • Create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e. mature) products.
  • Occasionally review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.
  • Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.
  • Collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, our Research & Development Division and across Divisions with Human Health Divisionand our Manufacturing Division to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities.
  • Support for Clinical Trial Applications (CTA's) in Phase I-III, Product, Registration and Launch (PR&L) filings, and post filing activities.
  • Participate in business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams.
  • Act as the Global Regulatory Team (GRT) Lead for assigned products.
  • May have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.

Minimum education required:

Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline with at least 4 years of relevant experience in the pharmaceutical industry. Alternatively a Master's or other advanced degree with at least 2 years of relevant experience in pharmaceutical industry.

Required experience and skills:

  • Previous industry experience is required. Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.
  • Must have excellent communication skills (both oral and written)
  • Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
  • Flexibility and negotiating skills are required.
  • Strong scientific and analytical skills.
  • Clinical experience is preferred.
  • Prior regulatory experience is preferred but not required.

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.

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.

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GRACSJOBS

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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.

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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.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:
$107,600.00 - $169,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

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Travel Requirements:

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Requisition ID:R243263

Client-provided location(s): Rahway, NJ 07065, USA
Job ID: Merck-2113513030
Employment Type: Other

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