• Job Description

  Req#: R270601

  Job Description

  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 minimal guidance of the Director, Business Development, the incumbent is responsible for representing Regulatory Affairs on business development transactions from deal initiation through potential signing. More specifically, this position will manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of Global Regulatory Affairs and Clinical Safety (GRACS) activities relating to our company's business partner deals for all types of business development arrangements including but not limited to divestitures, mergers, acquisitions, in-licensing, out-licensing, collaborations, distribution, co-marketing, and authorized generic agreements.

  • Throughout the business development lifecycle, the incumbent partners with appropriate functional areas within GRACS as well as Business Development, Clinical Research, Legal, and Alliance Management to support diligence, execution, and management of Business Deals

  • When required, under the oversight of the Director, support the drafting, negotiation, execution, and maintenance of both master agreements as well as regulatory agreements

  • Under supervision of the Director, coordinates and conducts due diligence on business development activities for all projects with GRACS functional area subject matter experts. Recruits and onboards due diligence team members to the due diligence project, facilitates discussions with GRACS due diligence team members to identify gaps and risks, tracks progress and coordinates GRACS due diligence summary reports, ensures GRACS Leadership is made aware of critical due diligence findings as needed, and liaises with GRACS Portfolio and Prioritization group to support GRACS resource estimation. Responsible for reviewing commercial contracts and collaborates with the Business Development Transactions group and GRACS SME’s to negotiate the GRACS related contract language with the partner

  • Coordinate with GRACS Business Development Execution Team to assist in the initiation of integration activities. Communicate GRACS deal-specific due diligence findings and contractual implications. Help facilitate cross-functional alignment of interdependent activities resulting from deal execution

  • Where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as the point of contact for alliance management issues including contractual questions related to ongoing GRACS activities and as required, lead execution and support of ancillary agreement creation, such as regulatory agreements

  • Update and track business development related projects and contracts within the Business Development Lifecycle Management system

  Education:

  • BS Degree preferably in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline

  Required Experience:

  • At least 5 years in the pharmaceutical industry in supporting functions that include Regulatory/CMC/Quality/Business Development/Pharmacovigilance

  • Knowledge of regulatory and CMC processes for pharmaceutical products, vaccines and/or biologic products

  • Working knowledge of worldwide regulatory requirements

  Preferred Experience:

  • Business Development transactions

  • Regulatory strategy supporting collaborations, licensing deals, or acquisitions

  • Familiarity with Clinical Development process

  • Ability to collaborate with multiple teams and effectively operate in a rapidly changing environment while being quality and compliance oriented

  • Must think critically, strategically, independently and problem solve

  • Must have high level of motivation and demonstration of our company's Leadership Values

  • Excellent written and verbal communication skills and negotiation skills including ability to write clearly and concisely

  • Excellent word processing, PowerPoint, SharePoint, excel, e-mail, and online meeting tool skills

  • Ability to work seamlessly with all levels of personnel

  • Demonstrated sensitivity and knowledge of cultural differences

  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 separationpackage, 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 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.

  We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

  EEOC Know Your Rights

  EEOC GINA Supplement

  Pay Transparency Nondiscrimination

  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.

  Learn more about your rights, including under California, Colorado and other US State Acts

  U.S. Hybrid Work Model

  Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

  Under New York State, 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’s relevant skills, experience, and education.

  Expected salary range:

  $118,640.00 - $186,800.00

  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 here.

  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:

  No relocation

  VISA Sponsorship:

  No

  Travel Requirements:

  10%

  Flexible Work Arrangements:

  Flex Time, Hybrid

  Shift:

  1st - Day

  Valid Driving License:

  No

  Hazardous Material(s):

  n/a

• About the company

  Merck & Co., Inc.,

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