Senior Specialist, Financial Disclosure US Subsidiary - Regulatory Affairs

Merck KGaA Darmstadt Germany • North Wales, PA

124d • $104,200 - $163,900 • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• Assures that Financial Disclosure data input is kept current.
• Tracks and maintains all regulatory submissions requiring the inclusion of financial disclosure information.
• Coordinates regulatory submissions with our Research & Development Division's Global Regulatory Liaison and Corporate Finance/Legal/Licensing Departments.
• Ensures compliance with regulatory requirements for reporting such information.
• Keeps current with regulatory changes affecting the department's core business.
• 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.
• 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.
• Serves as a Financial Disclosure SME for our Company's various collaborations, acquisitions, joint ventures, and licensing agreements.
• Provides 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree