Description

Job Description

Position Overview:

This Senior Specialist position is part of the GRACS US Subsidiary function within our Research & Development Division. Our mission is to serve as a trusted regulatory center of excellence and lead successful interactions with FDA regarding select US topics, primarily including: drug shortages, user fee compliance, import/exports, financial disclosure and freedom of information. This is an exciting time to join the US Subsidiary regulatory space, as we navigate evolving expectations and drive impactful change in our industry.

Under the direction of the Senior Director and Associate Director, the Senior Specialist Financial Disclosure US Subsidiary role is responsible for the tracking, coordinating and reporting of specified financial information to ensure compliance with the US Food and Drug Administration requirements for "Financial Disclosure by Clinical Investigators" for all marketing applications filed to the US FDA. Responsibilities include: (1) assures that Financial Disclosure data input is kept current, (2) tracks and maintains all regulatory submissions requiring the inclusion of financial disclosure information, (3) coordinates regulatory submissions with our Research & Development Division's Global Regulatory Liaison and Corporate Finance/Legal/Licensing Departments, (4) ensures compliance with regulatory requirements for reporting such information, (5) keeps current with regulatory changes affecting the department's core business.

Primary Activities may include but are not limited to:

Coordinates specified activities surrounding compliance to the US Food and Drug Administration regulation for "Financial Disclosure by Clinical Investigators" for all marketing applications filed with the FDA as required by that rule and provides ad hoc project support, as detailed below:

• Accountable for managing the financial disclosure business processes and components, overseeing a portfolio of approximately thirty compounds.
• Accountable for assuring collection of required financial information from clinical investigators, including appropriate due diligence details in the rare case that required financial information cannot be obtained.
• Responsible for the authoring of appropriate Financial Disclosure documents (FD Summary Document, FORM FDA 3454 and FORM FDA 3455, if applicable) for all assigned submissions to the FDA in compliance with the regulation.
• Coordinates our Research & Development Division's Corporate Finance, Legal, and Licensing searches to allow for the complete and timely tracking of required information through internal financial systems.
• As required, interacts with GRACS Global Regulatory Liaison, Regulatory Submission Manager, GCTO, and WMA planning teams to provide required Investigator financial information for new or supplemental applications that will be submitted to the FDA.
• Ensures the secured archival of all financial disclosure information required to support summary information provided to the FDA in compliance with all regulatory and corporate record retention requirements.
• Informs senior management when disclosure thresholds have been exceeded, to allow for the appropriate and accurate regulatory explanations / justification to support the control of financial bias in covered clinical trials.
• Serve as a Financial Disclosure SME for our Company's various collaborations, acquisitions, joint ventures, and licensing agreements. This also includes the ability to collaborate effectively with sourcing partners to align strategies and ensure smooth and efficient sourcing operations.
• Provide leadership support for special projects and initiatives, including contributing to or leading process optimization and continuous improvement efforts to enhance efficiency, quality and cross-functional collaboration.

Minimum Education and Prior Work Experience Requirement:

• BA/BS preferably in a science, health-related field or business

Required Experience and Skills:

• Minimum of 5 years of experience in Regulatory Affairs or Clinical Research
• Excellent written and oral communication skills required
• Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills, PowerBI/Power Apps, AI experience preferred)
• Flexibility and agility to respond and adapt to evolving regulatory and business processes
• Outstanding time management; the ability to balance a large project load
• General knowledge of database management.
• Ability to work independently with minimal guidance
• Efficient project management skills, delivering projects on time
• Ability to solve complex problems

Preferred Experience and Skills:

• Team Leadership experience
• Regulatory experience

Knowledge and skills in areas such as, but not limited to:

• Regulatory pathways and options, documentation; risk-benefit analysis techniques
• Working knowledge of eTMF and Clinical Trial Management systems
• 21 CFR Part 54 Financial Disclosure regulation
• Regulatory history, guidelines, standards, and requirements
• FDA submission process
• Regulatory agency inspection and compliance policies

Ability To:

• Work with diverse audiences and personnel
• Author and edit technical documents
• Think analytically
• Assess and interpret regulatory requirements and their impact
• Communicate clear and balanced evaluations
• Work in diversified cross-functional team environments to leverage a broad viewpoint on problem resolution

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".

The salary range for this role is
$104,200.00 - $163,900.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Adaptability, Adaptability, Asset Life Cycle Management, Audits Compliance, Clinical Information Systems, Clinical Site Management, Clinical Testing, Clinical Trial Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Finance, Global Communications, Joint Ventures, Management Process, Manufacturing Compliance, Oral Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Leadership, Project Management, Regulatory Affairs Management, Regulatory Compliance {+ 5 more}

Preferred Skills:

Job Posting End Date:
09/13/2025
*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:R363222