Associate Director, Regulatory Affairs Job

Employer
Merck
Location
Gwynedd, PA, US
Posted
June 01 2017
Organization Type
Pharma
Associate Director, Regulatory Affairs-REG002943

Description

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Regulatory Affairs Business Process Lead (BPL) is responsible for driving and leading meaningful business improvements and transformation change across Regulatory Affairs and Safety processes within Global Regulatory Affairs & Clinical Safety (GRACS). The Business Process Lead will regularly interact with senior management, process owners, subject matter experts, and stakeholders on vision setting, strategy, planning, and operational execution of strategic initiatives to solve the most pressing and challenging business problems. The Business Process Lead will collaborate across GRACS to continuously improve processes, documentation, and operational effectiveness of regulatory systems and ensure cross-functional alignment throughout the enterprise (e.g., Merck Research Lab, Merck Manufacturing Division, and Global Human Health ) to support development and improvement of enterprise-wide processes. The role will require a broad range of knowledge of global drug development processes and a detailed understanding of the business processes and requirements relevant to the Regulatory functional areas. The role will be responsible for oversight and management of specific sub-process spaces within the overall Regulatory process space.

Responsibilities Include:

- Ability to identify, define, plan, and project manage the execution of large-scale process re-engineering initiatives across GRACS, including facilitation of strategic planning sessions and leadership of initiatives.

- Leading and facilitating large and small-scale business process mapping sessions while working with process owners and functional SMEs to ensure processes meet business and compliance requirements. Document agreed upon processes or process changes working with Business Documentation Leads as required.

- Leading and facilitating Business Process Forums (BPFs) and working with stakeholders to identify and prioritize projects within assigned process space(s). Ability to project manage and/or coordinate multiple smaller projects conducted within the Regulatory Affairs and CMC Process Portfolio.

- Developing and presenting business case(s) to the Business Process Council and Portfolio Management Team to establish sponsorship and stage projects within overall GRACS change portfolio.

- Working with subject matter experts to ensure processes are consistent with current Health Authority (HA) regulations and policies

- Ensuring adequacy of process documentation output, including SOPs, Process Maps, RACI charts, and Execution Resources

- Leading and supporting development of project, communication, training, and change management plans

- Supporting development and implementation of process metrics and control plans

Qualifications

Education:

- Bachelor’s Degree with a minimum of 10 years of regulatory related experience or an advanced degree and a minimum of 8 years of regulatory related experience

Required:

- Must have a working knowledge of the processes, systems, and business requirements within Regulatory Affairs and/or CMC as it relates to product development, manufacturing, registration, post-marketing activities and lifecycle optimization.

- Experience facilitating workshops and focus groups with demonstrated experience assessing and enabling process change

- Strong skills in process mapping

- Strong analytical skills with a demonstrated ability to extensively analyze business processes and workflows

- Skilled in the management of project plans and executes with a sense of urgency

- Ability to lead by influence and work effectively in matrix organizational structures

- Demonstrated Change Management Knowledge

- Process Management Knowledge

- Ability to function at a high level of autonomy

- Ability to quickly adapt to changes in business priorities and effectively manage competing priorities

- Excellent facilitation, project management, problem solving, and written and verbal communication skills, including presentations to senior management

Preferred:

- Demonstrated experience in working in a cross-functional and cross divisional environment.

- Proficiency in Visio, Change Initiatives (e.g., Sigma), Change Management Certification, PMP Certification

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 staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Regulatory Affairs Generic

Job Title:Assoc. Dir, Regulatory Affairs

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Company Trade Name:Merck