Merck Senior Specialist, Portfolio & Program Management in Rahway, New Jersey
The Senior Specialist of Regulatory Planning & Publishing works closely with various stakeholders to drive the identification, planning, resourcing, execution, and management of activities to deliver high quality and timely regulatory and safety submissions for approval. The incumbent is expected to be skilled in project management with a demonstrated track record of leadership in a cross-functional setting. Capable of independent management of all submission projects and documents, at any level of complexity, across all submission types throughout the product lifecycle. Additionally, the incumbent may be involved in leading or supporting internal or external process improvement or strategic initiatives.
The responsibilities of the incumbent may include the following:
For assigned products, work closely with the Regulatory Lead to assess the overall program and manage submissions.
Capable of facilitating meetings effectively and clearly communicating decisions and action items to team members and relevant stakeholders.
Actively create and manage timelines maintaining a clear understanding of dependencies and critical path activities.
Have the skillset to identify, assess, and actively resolve or escalate, where necessary, any risks or issues that could impact the successful execution of submissions.
Education Minimum :
Minimum of 3 years’ experience in pharmaceutical/healthcare/consumer care industry/ in a project management/regulatory affair and/or pharmacovigilance/risk management function.
Ability to lead, influence, and work effectively in a matrix organization.
Ability to communicate effectively, both verbally and written, with others across levels within the organization.
Effective at establishing clear goals and assigning duties in a team setting.
Effective team facilitation with ability to establish collaborative team environments.
Detail oriented with the ability to drive overall strategy of projects/programs.
Desired Experience, Education & Skills:
Advanced degree preferred (engineering or scientific discipline, MBA).
Knowledgeable in the management and successful delivery of regulatory submissions.
Experience in project management methodologies (e.g., PMP, Sigma, Change Management, etc.) and associated toolsets (e.g., Microsoft Project for project planning, Microsoft Excel and/or PowerApps for data analysis and reporting).
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.
For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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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:
$97,680.00 - $153,700.00
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Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R222684
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