Head of CMC Technical Advocacy and Policy

Job Description

“New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.”

“As a science-based healthcare company with a longstanding commitment to inventing and providing important medicines and vaccines, subject to local law, we will require all U.S. and Puerto Rico based employees to be vaccinated by November 1, 2021, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.”

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

If you want to work for a company that is committed to improving the lives of its patients, has a strong product portfolio, and holds integrity and ethics in the highest regard, consider our company for your next career move.

If you have the drive and the passion to influence the global regulatory CMC environment for the advancement of innovative ideas to enable our company’s new technologies and pipeline, then consider this position.

Reporting to the Head of International CMC, CMC Project Management and CMC Technical Advocacy and Policy, the Executive Director, Global Regulatory CMC, will enable a coordinated, global, cross-divisional network for engagement opportunities to influence regulatory CMC innovation for the advancement of the technology and products most important for the company’s future success.

We are seeking a highly motivated CMC expert who will lead the company in developing and executing on external advocacy plans to globally progress innovative regulatory CMC positions aligned with the company’s goals. The ideal candidate will have significant experience building global regulatory CMC strategies and submissions and have demonstrated the ability to collaborate with and influence trade associations, peers and regulators on regulatory CMC initiatives.

This position will:

• Build a global, cross-divisional network from existing resources and provide leadership to ensure the company’s presence at the most appropriate external forums to provide an impactful advantage to the company’s objectives

• Work with subject matter experts in the global network to:

  • Centralize and prioritize the most important topics where the company can demonstrate leadership and drive the outcome of future CMC policy

  • Build well-developed positions coupled with the most successful Advocacy Plans for short- and long-term engagement

• Ensure the company understands regulatory trends, engagement opportunities and expectations of regulators regarding CMC topics via rapid and appropriate communications

• Oversee and evaluate the global agency guideline review processes to enhance the effectiveness of the evaluation, communication and implementation

• Provide input and collaborate directly with the Leadership in Regulatory CMC as well as Global Regulatory Policy

• Develop strong collaborative relationships with key cross-divisional Senior Leaders to effectively articulate the integrated needs of the CMC organization that best support the outcomes aligned with their functions

• Represent the company at key external forums and leverage the external network of regulators and industry to benchmark current trends

• Provide leadership to and develop team members to their fullest extent as well as indirectly guide key CMC subject matter experts within vaccines, biologics and pharmaceutical CMC teams on policy-related matters

• Recognize, reward and promote direct reports and network members in support of the company values and in line with behaviors expected of our leaders

Education:

• Degree in pharmacy, chemistry, engineering, biology or a related discipline

• Advanced degree (Ph.D.) in Sciences or Engineering is preferred

• Excellent communication, stakeholder management and influencing skills, as well as the ability to manage ambiguity

Required:

• 15-plus years of senior level experience in pharmaceuticals, biotech, or at FDA/EMA leading a part of a global CMC organization

• External network that includes regulators and industry colleagues

Preferred:

• Significant experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance)

• Strong external network of regulators and trade associations and experience partnering with agency and industry members towards a specific regulatory initiative

• Prior leadership positions gained in roles which include drug product & analytical development, all phases of product development/and or supply chain for clinical and commercial supplies, coupled with significant direct regulatory CMC experience

• Comprehensive understanding of quality and regulatory compliance, plus an understanding of the various regulatory requirements worldwide, as well as direct engagement experience with regulators

• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data

• Demonstrated ability to develop innovative approaches to problem solving and to respond to changing priorities or unexpected events with great agility

• Superb collaboration and stakeholder management skills, rapid and disciplined decision making and critical thinking capabilities, as well as ability to work well under pressure

• Excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams, including those that are not direct reports, as well as external experts

• Demonstrated experience in building, rewarding and retaining key talent

• Proficient in English; additional language skills are a plus

GRACSJOBS

#EligibleforERP (Program available to employees in the US & Puerto Rico)

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

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

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Valid Driving License:

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Requisition ID:R143332