Job Description
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
Information Technology Risk Management and Security Governance Risk and Compliance (ITRMS GRC) is an essential component of the current IT enterprise that provides support to the Pharmaceutical Research, Supply Chain, and Marketing organizations. The IT Compliance Consultation group is responsible for working directly with IT practitioners to provide guidance on navigating the company's System Development Lifecycle (SDLC) and the IT Control framework.
The Senior Specialist Compliance Partner will engage with stakeholders as a trusted partner providing consultation services and leadership for the SDLC and the IT Control framework. This role reports to the IT Compliance Consultation Lead.
Responsibilities:
- Engage with IT practitioners and provide expertise for the SDLC, Compliance Risk Profile, Digital SDLC, and the IT Control Requirements Set.
- Represent IT Compliance as a single point of contact and advise project teams on the SDLC tailoring/risk-based implementation strategy.
- Interpret IT Controls (based on current regulatory requirements) and providing independent support to practitioners.
- Support strategic engagements that may require setting up processes and compliance artifacts to drive operational efficiency.
- Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations, and facilitating strategic decisions with senior management.
- Initiate training and workshop for knowledge transfer and adoption of Agile SDLC principles.
- Ensure that the IT organization operates and complies with established policies/procedures.
- Establish new or improved guidance and drive consistent, standard methods across the IT divisions.
- Support audit/inspection readiness and participate in the timely review and CAPA response.
Education:
- Bachelor's Degree is required. Concentration in an Information Technology or related field is preferred.
Required Skills & Experience:
- The ideal candidate will have some exposure to at least one of the following: research, manufacturing, Infrastructure, or security.
- 5+ years working in IT , Quality, or Compliance in Life Sciences.
- Demonstrated ability to establish and maintain collaborative relationships with stakeholders.
- Clear understanding of principles, procedures and governance of validation activities and IT controls.
- Understanding of emerging technologies used in the IT industry, such as cloud, mobility, social, data science, and analytics platforms.
- Knowledge of Regulations: 21 CFR Part11, Annex 11, etc.
- Experience in systems validation and quality frameworks.
GRC2021
Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
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 ...
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.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Remote Work
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
Number of Openings:
3