Job Description

The Future Talent Program features co-ops that last up to 12 weeks and will include one or more projects. These opportunities in our Research & Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals.

Team Overview:

The Global Regulatory Affairs and Clinical Safety (GRACS) Regulatory Digital Health (RDH)/IQSE Policy Execution team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world through a highly regulated industry. We have accountability to both lead the enterprise, navigate the ever-evolving digital health regulations, and to ensure the Innovation, Quality, and Strategic Execution (IQSE) organization within GRACS is aware, understands, and implements the latest regulations and guidances globally.

Position Overview:

Under the direction and guidance of the RDH/Policy Execution leadership team the incumbent will assist in executing the overarching strategy for all Digital Health Modalities including, but not limited to: Clinical trial tools, tools used to analyze data, and commercial innovations as well as developing processes and partnerships across IQSE in partnership with RDH and IQSE Policy Execution team members. The responsibilities may include leading or supporting one or more projects related to Project Management, Administrative support, Digital Health related programs among others. These opportunities in our department can provide opportunities for development for your long-term goals.

Primary duties/assignments :

• Provide Regulatory Digital Health and IQSE Policy Execution leaders with administrative support

• Support the assessment, communication, and implementation of the emerging Digital Health Regulatory landscape across the company portfolio

• Collaborate with the IQSE Policy Execution Team for the assessment, implementation, and tracking of new and updated global regulatory policies for IQSE (Innovation, Quality, and Strategic Execution).

• Conduct assigned policy reviews to boost organizational risk management initiatives, including providing audit/assessment support

• Build familiarity with GRACS systems enabling departmental support for initiatives, remediation efforts, and product research (i.e., submissions, registration, regulations, risks, etc.)

• Participate and support as appropriate, operational processes and systems to incorporate Digital Health into the company across the product portfolio

• Candidate may be required to do research on global agency sites and participate in meetings and conversations around related to Medical Devices

• Contribute to the strategic vision and planning of new digital health initiatives that establish operational processes and systems to fully incorporate device and digital health into our company’s way of working across the broad product portfolio.

• Ensure close collaboration with cross functional and cross divisional teams (Research, Manufacturing, Commercial, IT) to align on and incorporate regulatory requirements into strategies for digital health solutions and complex combination products (with connectivity) to ensure successful product registrations

• Development of best practice guidance for regulatory deliverables for digital health, diagnostics, and complex combination products to support the therapeutically aligned development teams

• Schedule as needed and actively facilitate discussions and interactions with cross functional and cross divisional teams and/or external partners

NOTE: This co-op is available in North Whales, PA or Philadelphia, PA based on candidate preference. Occasional travel to our Rahway, NJ site may be required.

Education:

• Candidates must be currently enrolled in a Bachelor's degree or higher education in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field
• Candidates must have completed at least two (2) years of coursework towards a Bachelor's degree by the start of the Co-op

Required Experience and Skills:

• Candidates must be able to commit to full-time hybrid employment for 4 - 6 months beginning January 2024
• Must be willing to learn and grow their knowledge in the global regulatory requirements landscape for Drugs, Digital Health Technologies, and/or Medical Devices and the regulatory policies that govern these requirements
• The ability to work with teams across the enterprise in the execution of tasks or process implementation

• Possess excellent written communication skills

• Exhibit attention to detail during execution, review and assessment of tasks

• Display flexibility and agility in adapting to changing situations, while maintaining, a high level of performance and delivering results

Preferred Experience and Skills:

• Candidate enrolled in a Master's or Ph.D. degree program

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:

$39,600.00 - $105,500.00

FTP2024

MRL2024

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

Current Contingent Workers apply HERE

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

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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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.

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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”.

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:

Intern/Co-op (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A