Job Description

The Regulatory Affairs International Headquarters (RAI-HQ) R3, Senior Scientist position is a broad role encompassing all aspects of regulatory strategy including Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety, risk management, and labeling. They have direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products. The Senior Scientist reports to a Director in RAI-HQ.

The Senior Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.

Specific responsibilities (with coaching and managerial oversight) include:

Create and drive implementation of a Most of World (MOW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.

Create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e. mature) products.

Occasionally review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.

Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.

Collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, our Research & Development Division and across Divisions with our Human Health and our Manufacturing Division to ensure alignment around a common set of priorities and objectives for MOW filings and lifecycle management activities.

Support for Clinical Trial Applications (CTA\xe2\x80\x99s) in Phase I-III, Product, Registration and Launch (PR&L) filings, and post filing activities.

Participate in business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams

Act as the Global Regulatory Team (GRT) Lead for assigned products

May have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.

Required Qualifications/Experience:

Previous industry experience is required.

Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.

Experience in Oncology is desired but not required.

Education:

Degree in Pharmacy, Biological Science, Chemistry, Engineering, Nursing, or related discipline.

Requirements:

Bachelor\xe2\x80\x99s degree, preferably in Pharmacy, Biological Science, Chemistry, Engineering, Nursing, or related discipline required with at least 4 years of relevant experience in the pharmaceutical industry.

Alternatively a Master\xe2\x80\x99s or other advanced degree with at least 2 years of relevant experience in pharmaceutical industry.

Must have excellent communication skills (both oral and written)

Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.

Flexibility and negotiating skills are required.

Strong scientific and analytical skills.

Prior regulatory experience is preferred but not required.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we \xe2\x80\x9cfollow the science\xe2\x80\x9d 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 \xe2\x80\xa6

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 \xe2\x80\xa6

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\xe2\x80\x94and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with 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.

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.

Current Employees apply

Current Contingent Workers apply

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 if you need an accommodation during the application or hiring process.

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

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\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City, Colorado State, 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\xe2\x80\x99s relevant skills, experience, and education.

Expected salary range: $107,600.00 - $169,400.00

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 .

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: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Merck & Co.