Associate Director, Regulatory Affairs, Regulatory Requirements and Intelligence Lead Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Regulatory Requirements and Intelligence Team Lead will actively drive towards a future state vision of requirements management for the organization, working broadly across functional areas. The lead will set the strategy for an expanded scope of regulatory requirements beyond the existing capability. To this end, the Lead will identify the strategic scope of requirements management needed to support GRACS global submissions through the engagement of stakeholders cross-divisionally. The Lead will articulate a concise integration of requirements in the system framework, and manage efforts to capture regulatory requirements from global stakeholders. Further, the Lead will own and ensure ongoing maintenance of the existing requirements management database, RED Compass, and the associated cross-divisional processes. The Lead will develop and execute on a strategy to ensure that future state requirements management supports the organizational efforts to increase “right first time” submissions. The Lead will have the responsibility to develop, implement, and oversee a sourced support strategy for engaging third party resources to maintain and update requirements management data.
The Lead will be responsible for the establishment of regulatory intelligence information management across the business capabilities and functional areas of Global Regulatory Affairs & Clinical Safety (GRACS). The incumbent will lead the development of the regulatory intelligence information management strategy and will have responsibility for the execution of that strategy. This individual will collaborate with capability owners, functional area representatives, process owners, third party providers, and MRL IT to establish regulatory intelligence information management and governance.
The Lead will develop a capability for the information management of Health Authority (HA) Interactions to support business intelligence and decision-making. This includes the development of a technology solution to allow GRACS functional areas to access the extensive HA Interactions information assets to answer important business questions related to future submissions and the development of regulatory strategy. The Lead will collaborate cross-divisionally to develop and execute on a strategy for accessing Merck’s database of HA Interactions to develop a new capability around business intelligence.
The Lead will support the development of an information management capability to manage regulatory intelligence, whether developed internally or by a third party provider or subscription service. These responsibilities include the development of process, technology, and organizational design to manage these information assets.
Responsibilities for the Regulatory Intelligence Team Lead include but are not limited to:
- Managing a team of 2+ content and technical experts and several sourced support resources to ensure timely revision of RED Compass data through change control processes
- Driving consensus and issue escalation, as necessary, through the RED Compass Governance structure
- Supporting users through training on RED Compass system and tools and ensuring that all processes are adequately documented and communicated
- Liaising with key stakeholders to understand ongoing needs around regulatory requirement data sets
- Driving efforts to integrate data needs into the framework of the RED Compass system and gathering regulatory requirements from global stakeholders
- Evaluating metrics for the RED Compass system, including volume of change requests/data additions, turn-around time, and opportunity areas
- Representing RED Compass on cross-functional teams and actively participating in initiatives to improve data and increase “right first time” submissions.
- Develop strategic direction on Regulatory Intelligence Information Management capability and liaise with key stakeholders to identify needs and define solutions
- Bachelor’s degree with a minimum 8+ years of industry experience, at least 6 of those in a regulatory and/or compliance area OR Master’s Degree and a minimum of 6 years of industry experience, at least 4 of those in a regulatory and/or compliance area
- Broad organizational awareness
- Ability to work comfortably across multiple levels within an organization, including executive sponsors
- Ability to effectively communicate with a broad range of key stakeholders and to articulate needs into actionable data requirements
- Expertise in Excel and TeamSpace
- Project Management Skills
- Ability to lead /influence without authority
- Personnel Management/Coaching/Mentoring skills
- Excellent Communication and facilitation skills
- Knowledge of CMC and Ancillary Document requirements in support of registrations and renewals
- Familiarity with reporting tools such as Spotfire
- Experience leading sourced teams
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Regulatory Affairs Generic
Job Title:Assoc. Dir, Regulatory Affairs
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Regulatory Affairs, Manager, Defense, Law, Compliance, Legal, Management, Government