Job Description

As key lead alongside the AVP of Medical Device and Combination Product (MDCP) Regulatory and Quality, this role provides leadership to design and build the strategy, process, and transformational initiatives for the MDCP Regulatory and Quality organization as a key part of the broader Research Division/Manufacturing Division efforts to transform our Devices capability. Partners with the AVP of MDCP Regulatory and Quality to develop strategies and processes enabling successful integration of CMC MDCP Regulatory and Quality into the enterprise device and combination network from product development through commercialization. Effectively integrates the broad network within our Research Division and our Manufacturing Divisi to develop a collaborative process that enables registration and commercialization of devices and combination products. Successfully partners with stakeholders throughout the value chain to ensure execution of the change agenda to enable the transformational requirements for the organization.

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.

The primary activities may include but are not limited to the following:

Identification, evaluation, and recommendation of key MDCP Regulatory and Quality strategies to drive transformation of the broad devices network areas and associated processes.

Partnership with leaders in our Research Division and our Manufacturing Division Technical areas and DCRC to shape and progress overall Device processes and capabilities to successfully progress the pipeline programs.

Maintain deep enterprise structural and process understanding and connectivity crucial to MDCP Regulatory and Quality.

Evaluate, generate and/or streamline MDCP Regulatory and Quality business processes and way of working.

Promotes overall connectivity of MDCP Regulatory and Quality to the broader organization.

Supports the MDCP Regulatory and Quality AVP in strategic discussions and in communicating critical business aspects within and outside the organization.

Acts as a single point of contact for MDCP strategy and business process.

Defines prioritization of initiatives with a direct link to the overall CMC Strategy to ensure focus on what matters most while

Has high-level knowledge and ability to apply knowledge of global device and drug/device combination product guidelines regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking and established company business processes and systems.

Has demonstrated record of leading significant programs that require unique or progressive approach to defining significant change in processes or organization operation.

Collaborate with broader device organization and other stakeholders to communicate and align on new regulations and requirements to ensure optimal MDCP Regulatory and Quality strategies and business processes.

Support evaluations of regulatory and quality state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions as required.

May participate in resolving project issues through collaboration with the team and escalation to the DDDC (Devices and Drug Device Combination) leadership team as appropriate.

Superior oral and written communication skills in global settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.

Sound understanding of related fields and the ability to be creative and imaginative in the approach to new and diverse problem solving.

Ability to be creative and imaginative in approach problem solving and to generate innovative solutions to complex regulatory and quality problems and effectively work with and communicate to key stakeholders.

Demonstrates flexibility in responding to changing priorities or dealing with unexpected events.

Demonstrates effective leadership, decision making, communication, interpersonal and negotiating skills.

Qualifications, Skills & Experience

Bachelor\'s degree in a science, engineering, or a related field (advanced degree preferred)

5+ years of experience in Bio/pharmaceutical industry required.

Preferred at least 3 years of managerial experience or demonstrated leadership experience with project teams.

Preferred at least 3 years of MDCP Regulatory or Quality or technical related experience, with demonstrated understanding of pharmaceutical operations.

Increased expectations for influencing decision making and ability to obtain consensus with senior stakeholders and external presence.

Demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.

Must be proficient in English; additional language skills are a plus.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we \xe2\x80\x9cfollow the science\xe2\x80\x9d 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 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

to request this role\xe2\x80\x99s pay range.

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

Current Contingent Workers apply

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 if you need an accommodation during the application or hiring process.

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

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\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday \xe2\x80\x93 plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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\xe2\x80\x99s relevant skills, experience, and education.

Expected salary range: $130,960.00 - $206,200.00

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 .

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: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

Merck Sharp & Dohme