Director Regulatory Affairs Liaison - Diagnostics

Job Description

Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient and compliant drug/diagnostic regulatory strategies and approaches across geographies.

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.

Under direction of the Executive Director, Companion Diagnostics/In Vitro Diagnostics, the Principal Scientist/Director will be responsible for:

• Providing critical strategic and tactical CDx/IVD regulatory guidance that positively influences project planning and decision making.

• Developing regulatory strategies for assigned products to enable and/or support timely approval of both therapeutic and diagnostic products by regulatory agencies.

• Representing the Global CDx Regulatory position and providing updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners.

• Coordinating and leading regulatory interactions with diagnostic partners and/or regulatory health authorities, as needed, to mutually align on co-development needs and expectations for major project tasks such as regulatory submissions (e.g., PMAs, 510(k)s, IVDR submissions to NB, IDEs, EU performance study applications, pre-submissions).

• Participating in meetings with regulatory agencies in collaboration with diagnostic partners and/or internal teams.

• Reviewing and authoring relevant sections of device regulatory submissions, as appropriate, and corresponding therapeutic dossiers.

• Interacting with global regulatory authorities and diagnostic partners to determine best practices and least burdensome regulatory paths to facilitate development and global registration activities.

• Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products.

• Providing regulatory support for due diligence activities, as needed.

Education:

• Required: Bachelor’s degree in biological science, chemistry or related discipline, with minimum of 10 years of relevant experience in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs.

• Preferred: M.S. with minimum of 8 years of relevant regulatory experience; PharmD or PhD with minimum of 6 years of relevant regulatory experience.

Experience and Skills:

• Diagnostics/In Vitro Diagnostics and/or Oncology diagnostics experience

• Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.

• Outstanding interpersonal communication and negotiation skills.

• Demonstrated leadership attributes and ability to drive success consistent with company values and priorities.

Position available at the following locations:

• (Upper Gwynedd, PA, Rahway, NJ, Rockville, MD, Boston, MA).

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.

Who we are …

We are known as Merck & Co., Inc., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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.

Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R229480