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Merck Associate Director – Compliance Consultation Lead  in Boston, Massachusetts

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 Associate Director – Compliance Consultation Lead will partner with the company’s IT divisions and support functions, including Manufacturing, Research & Development, Marketing, Infrastructure, Security, and Animal Health, to provide consultation service and leadership for the SDLC and the IT Control framework. The Compliance Consultation Lead also provides training and guidance to product and application teams concerning the authoring of SDLC/validation deliverables and good testing and documentation practices. This role reports to the IT GRC IT Compliance Consultation Service Line Lead.

Responsibilities:

  • Manage a team of Compliance Partners providing consultation services in at least one of the following areas manufacturing, research and development, commercial, infrastructure, security, and/or automation

  • Partner closely with IT divisions and practitioners to reduce time-to-production and project cost through streamlined system development lifecycle and reduced documentation

  • Educate and enforce adherence to standard operating procedures and guidelines required under the company’s SDLC

  • Build collaborative working relationships and effective communications with divisional stakeholders (at all levels) in manufacturing, research, quality assurance, regulatory, etc.

  • Work closely with the Policy and Process Governance Lead to provide input into the SDLC policy and IT Control framework

  • Establish company-wide SDLC training program to transfer Agile SDLC and compliance skills into the organization effectively

  • Establish an IT Compliance Center (e.g., Technology CoP) to provide self-service SDLC capabilities

  • Support strategic engagements (e.g., BlueSky, IT Transformation) that may require setting up processes and compliance artifacts to drive operational efficiency

  • Monitor key performance indicators and ensure expectations are met; develops action plans when needed

  • Manage service demand and delivery, and work with the Service Lines to ensure supported systems are audit and inspection ready

Desired Education Level:

  • 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

  • 8+ years working in IT, Quality or Compliance in Life Sciences

  • Technical knowledge and understanding of System Development Life Cycle, GxP principles, and computer validation

  • Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution

  • Demonstrates an executive presence through good communication and professionalism

  • Strong leadership, analytical and organizational skills

  • Understanding of emerging technologies used in the IT industry, such as cloud, mobility, social, data science, and analytics platforms

Preferred Experience and Skills:

  • Hands-on Agile experience in a regulated industry is a plus

  • Experience working with Jira, Confluence, and other Scrum/DevOps tools

  • Experience working in a consultation or client-facing role

  • Experience with regulated GxP Pharmaceutical IT Systems

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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3

Requisition ID: R131011

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