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Senior Specialist, Business/Tech. Analysis (Remote)

at Merck in Dover, Delaware, United States

Job Description

Job Description

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.

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.

The Technical Analyst will be part of the Submission Authoring and Source Content Product Team working on content management solutions across regulatory IT in support of the Research and Development business area. Under the leadership of the product manager the incumbent will work closely with business partners to design and develop solutions for the defined business needs.

Key tasks include:

+ Accountable for the solution design and delivery of Regulatory Affairs content management systems in support of new business processes.

+ Responsible for design and management of downstream and upstream integrations to regulatory content management systems.

+ Align applications with our Company’s defined IT strategies to insure architectures are aligned with the strategic IT programs such as cloud, master data and security.

+ Maintain and contribute to application roadmaps and strategic planning for application expansion and new capabilities.

+ Contribute to innovation, and thinking/working “out of the box” as appropriate and when possible to achieve efficiency for a better user experience.

+ Keep abreast of new technologies, work processes, industry practices, and standards.

+ Interact with business users, solution/software providers, and IT colleagues to brainstorm and implement solutions.

+ Proactive participation in defining system design, system, and user acceptance testing, and ensure completion of required GxP and our Company’s Systems Development Lifecycle (SDLC) documentation.

+ Contribute to track performance of production support activities and escalate concerns in an appropriate forum for corrective action.

+ Ensure activities are conducted in compliance with company policies and standards, in addition to regional and country specific regulations.

Qualifications:

Education:

+ B.A./B.S. or equivalent experience in Computer Science, Engineering, MIS, and Science or in a related field.

Prerequisites:

+ Minimum 5 years or equivalent with large scale validated scientific computer systems.

+ Minimum of 3 years of engineering and solution delivery with GxP systems.

+ Demonstrated ability to analyze and define business problems and identify appropriate technology solution(s).

+ Strong teamwork and partnership skills.

+ Drive for results augmented by strong planning and organization skills.

+ Deliver customer value – dedicated to understanding and meeting customer needs.

+ Partners effectively with and through others to achieve common goals.

+ Strong Communication skills for verbal, written, and technical presentations.

+ Demonstrates ethics and integrity.

Preferred:

+ Has worked in Clinical, Regulatory, Quality, and/or Safety IT, and relevant business areas.

+ Has worked with architecture, integration, interfaces, portals, and/or analytics.

+ Experience with OpenText Documentum and D2 configurations, Calyx, Veeva Vault RIM, workflow tools (Appian, TIBCO, Active Matrix, Uipath), and API frameworks (Apigee).

+ Experience with validated health authority regulatory (HAR) capabilities, SDLC, inspection and audits.

+ Experience working with on premise, Cloud capabilities, and software as a service (SaaS).

+ Experience with Agile Methodology.

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.

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 agr

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Job Posting: JC202402208

Posted On: Jan 20, 2022

Updated On: Mar 05, 2022