Job Description

The mission of Global Medical and Value Capabilities (GMVC) is to drive and innovate world class Medical & Value Capabilities to advance research and scientific exchange, improving access and health outcomes for patients. The Research Management team sits within the Research Execution organization and provides support across all elements of management and execution of non-interventional studies and research activities. This position, under the supervision of an Associate Director, will execute a variety of research management activities starting from study execution to close-out and summarization of results from observational research activities. Research managers will be aligned by department/TA for activities under Value Evidence and Medical Plans (VEAMs).

Research Management Role

Coordinates all aspects of observational or non-interventional research activities which includes (but is not limited to) the implementation of primary data collection, chart review/survey, and database studies, health economic model development and adaptations, and other activities in support of HTA. Support Scientist(s) by providing overall operational support for research conduct in compliance with Good Pharmacoepidemiology Practice (GPP), Company Policies, and Standard Operating Procedures (SOPs).

Primary responsibilities include:

• Operational support of observation/non-interventional research activities including execution, and close out of primary data collection, chart review, database studies in addition to other activity types

• Liaise with and provide oversight/direction to suppliers and communicate with internal cross-functional teams to share project status and mitigations

• Track timelines/deliverables and follow up on action items (vendor and internal teams/scientists)

• Assist with review and finalization of all supplier documents such as monitoring, project management, safety management, data management and validation plans

• Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and submit to the internal repository

• Coordinate internal/external meeting management and draft/review agenda/minutes

• Ensure studies follow all non-interventional processes for informed consent, compliance, site contract and budget review/approval, protocol document review, study registration (when applicable), adverse event reconciliation, publication submission and close out.

• Ability to understand, describe and document (when applicable) procedures/compliance requirements for observational studies to internal and external stakeholders such as outside investigators/suppliers and key opinion leaders.

• Coordinate confidentiality, consultant agreements and external engagement meetings

• Participate in quality control and integrity of study data and reports for publications

• Manage publication development including formatting, figure/data content development, co-author review, internal review process, and journal submissions

• Collaborate and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of activities

• May participate in mentoring other research managers

Education and Experience:

• Bachelor's degree required in life sciences or public health (or closely related discipline, such as epidemiology, health administration or biological sciences)

• One (1) or more years of work experience within clinical/observational research or equivalent.

Required Skills:

• Strong project management skills.

• Strong communication and interpersonal skills.

• Basic knowledge of epidemiologic or outcomes research.

• Highly motivated, able to work collaboratively and independently.

• Solution oriented, timely and detailed-oriented.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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):

Number of Openings:

Requisition ID:R200248