Program Specialist, Regulatory Planning and Execution ( MERCUSR151029ENUS)
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.
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.
The Specialist works closely with various stakeholders of regulatory/safety submissions to assist in planning, resourcing, execution, and management of activities that deliver high quality and timely regulatory submissions. Additionally, the incumbent may be involved in supporting internal or external process improvement or strategic initiatives designed to improve the efficiency and effectiveness of the RPE (Regulatory Planning & Execution) processes and deliverables.
In partnership with the submission planning team, actively participates in planning forum meetings to assist with submission activities which may include (but not limited to): RTQs (response to questions); submission plans; issue identification; etc.
Helps identify business process improvement opportunities, documentation updates and/or training to prevent practices which could lead to quality deviations or non-compliance events.
Liaises with all pillars of the RPE organization to ensure timely and quality submissions, as the business requires.
Responsible for the creation of submission plans in the planning tool to ensure correct components and timelines are captured.
Required Experience and Skills:
1+ years of working experience within a healthcare/consumer care industry project management, regulatory affairs, and/or pharmacovigilance/risk management function.
Ability to communicate effectively, both verbally and written, with others across cultures, organizational level and disciplines within a matrix organizational structure.
Ability to understand tactical details, but keep overall “big picture” view of projects and strategies.
Self-starter, fast learner with analytical and problem-solving capabilities and the ability to innovate and perform in a fast-paced team environment
Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills preferred).
Highly organized with keen attention to detail.
Demonstrated leadership, initiative and ownership of deliverables.
Effective at energizing others, establishing clear goals, delegating responsibility, mentoring and coaching.
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
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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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.
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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.
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