Job Description

We have a great opportunity for an Associate Principal Scientist to join our global team.

We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world.

Join us in our mission to shape and facilitate the strategic plan and ongoing transformation of our CMC organization, part of Global Regulatory Affairs and Clinical Safety (GRACS).

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Lead, support or project manage the design and implementation of cross-regional or functional business strategies, process improvement initiatives, and operating model projects in collaboration with our strategic partners.
• Support communication on initiatives progress and implementation, keeping the organization informed and supporting associated change management activities.
• Coordinate and contribute to the delivery of the Regional CMC strategic plan, operating model transformation initiatives, and key priorities.
• Support the management of Regional CMC priorities, roadmap, scorecards, and dashboards.
• Digital transformation, including supporting Digital capabilities build in the Regional CMC team.
• Strengthen Regional CMC’s partnerships with other GRACS and broader enterprise stakeholders across regions, including other GRACS functions, our research & development division functions, and other divisions (HH: Sales, Marketing, our manufacturing division: Supply Chain, Quality).
• As required, develop CMC regional regulatory strategies for new marketing applications and post-approval changes.

In order to excel in this role, you will more than likely have:

• Minimum of 5 years’ experience in regulatory affairs,
• 2+ years’ experience in project and change management,
• Strong collaboration and communication skills.
• Ability to manage complex projects and initiatives with limited supervision.
• Strong digital skills and familiarity with digital tools and platforms is required
• Enterprise mindset with an ability to think strategically across the organization.
• Experience in managing cross-functional teams and working with strategic partners.
• Experience with CMC regional regulatory strategies is preferred though not essential

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Accountability, Accountability, Adaptability, Biologics License Application (BLA), Business Strategies, Change Management, Collaborative Communications, Collaborative Development, Cross-Cultural Awareness, Detail-Oriented, Digital Transformation, Electronic Common Technical Document (eCTD), Employee Training Programs, International Regulatory Compliance, Mentorship, Pharmaceutical Process Development, Process Improvement Projects, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions, Regulatory Writing {+ 4 more}

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights:

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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, Monday
• 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”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/5/2026

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.