Director, Devices and Drug-Device Combinations -CMC (Hybrid)

Job Description

This Principal Scientist position is equivalent to a Director position. Under direction from Executive Director, the Principal Scientist is responsible for implementing Devices and Drug-Device Combinations (DDDC) regulatory strategies for our organization in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the preparation and submission of combination product sections for commercial or new products such as pre-filled syringes and autoinjectors. The Principal Scientist will lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching as required.

The Principal Scientist responsibilities include but are not limited to:

• Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings.
• Serve as a Regulatory Project Lead and provide Regulatory leadership within Regulatory and on cross-functional teams for the assigned device and combination products in development or commercial products.
• Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions according to defined timelines.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions
• Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory leadership team as appropriate.
• Collaborate with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant for the combination product. Participate in activities and teams related to device and combination products
• Support device design control activities and documentation reviews
• Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions
• Careful planning, tracking, and communicating regarding submissions and approvals to support continued product supply
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve combination product content or processes may also be required, as needed
• May need to manage or mentor junior team members

Education Minimum Requirement:

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical, Mechanical and Electrical Engineering, Biology, Microbiology, or Biochemistry.

Required Experience and Skills:

• A minimum ten (10) years of industry / regulatory experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturing
• Experience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device product, preferably an autoinjector
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
• Strong knowledge and understanding of design controls process

Leadership Skills:

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
• Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities

Preferred Experience and Skills:

• Subject matter expertise in combination product regulatory development and manufacturing
• Strong knowledge and understanding of design controls process
• Preferred fields of study include Biology, Biochemistry or Engineering

NOTICEFORINTERNALAPPLICANTS

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.

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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 - 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's relevant skills, experience, and education.

Expected salary range:
$175,440.00 - $276,200.00

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 here.

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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

Requisition ID:R250799