Merck & Co Hiring for Scientist Regulatory Affairs Liaison, Specialist – Oncology (Hybrid) job in Rahway Full Time

Our company’s Oncology Global Regulatory and In vitro Diagnostics team is looking for a Regulatory Support resource.

In this exciting, rewarding role, the position will support products in the oncology therapeutic area. Candidate will have excellent communication and collaboration skills and will work closely with cross department Global Regulatory Liaisons (GRL) to help implement a global strategy for registration of oncology products and help manage regulatory submissions. Specific responsibilities (with coaching and managerial oversight) include but are not limited to:

• Assist in coordinating and tracking the development and review of documents associated with regulatory submissions of marketing applications and INDs which may include responses to Agency requests, Agency meeting requests and background packages, Pediatric Study Plans, FDA cover letters, etc.
• Prepare and maintain detailed timelines for regulatory deliverables.
• Assist GRLs in maintaining records of communications/contacts with Agencies, including archiving of communications.
• Assist GRLs with development of agency meeting requests and background packages including initiating and managing documents in business systems.
• Schedule cross-functional meetings as required, in collaboration with, and to assist the global regulatory liaison.
• Conduct research and review of guidelines, regulatory precedents, competitive products to assist in developing regulatory strategy documents.
• Perform regulatory administrative activities as needed in support of the Therapeutic Area.
• Preparing job aids.
• Perform real-time tracking various department metrics to support leadership.
• Assisting with updating/maintaining the department OneNote Best Practices/Key Information notebook.

Education Minimum requirement:

Degree in Pharmacy, Biological science, Chemistry or related discipline

Bachelor’s degree, preferably in Biological Science, Chemistry or a related discipline with relevant experience in the pharmaceutical industry, preferably regulatory affairs.

Required experience and skills:

• Minimum of 2 years experience.
• Excellent communication skills (both oral and written).
• Good organizational and project management skills with a proven ability to balance diverse activities for multiple projects.
• Strong scientific and analytical skills.

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.

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.

Current Employees apply HERE

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. – All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. – For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:
$80,320.00 – $126,500.00

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 .

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R255756