Merck Jobs

Job Description

Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and compliant drug/diagnostic regulatory strategies and approaches across geographies.

Under direction of the Executive Director, Companion Diagnostics/In Vitro Diagnostics, the Principal Scientist/Director will be responsible for:

• Providing critical strategic and tactical CDx/IVD regulatory guidance that positively influences project planning and decision making.

• Developing regulatory strategies for assigned products (non-oncology/oncology) to enable and/or support timely approval of both therapeutic and diagnostic products by regulatory agencies.

• Representing the Global CDx Regulatory position and providing updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners.

• Coordinating and leading regulatory interactions with diagnostic partners and/or regulatory health authorities, as needed, to mutually align on co-development needs and expectations for major project tasks such as regulatory submissions (e.g., PMAs, 510(k)s, IVDR submissions to NB, IDEs, EU performance study applications, pre-submissions).

• Reviewing and authoring relevant sections of diagnostic regulatory submissions, as appropriate, and corresponding therapeutic dossiers.

• Interacting with global regulatory authorities and diagnostic partners to determine best practices and least burdensome regulatory paths to facilitate development and global registration activities.

• Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products.

• Providing regulatory support for due diligence activities, as needed.

Minimum education required:

Required: Bachelor’s degree in biological science, chemistry or related discipline, with minimum of 10 years of relevant experience in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs.

Preferred: M.S. with minimum of 8 years of relevant regulatory experience; PharmD or PhD with minimum of 6 years of relevant regulatory experience.

Required Experience and Skills:

• Diagnostics/In Vitro Diagnostics. Experience in Oncology/non-oncology companion/complementary diagnostic development is preferred.

• Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.

• Outstanding interpersonal communication and negotiation skills.

• Demonstrated leadership attributes and ability to drive success consistent with company values and priorities.

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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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 (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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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 State, 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:

$164,800.00 - $259,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/1/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 07/01/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R298521