Technical Lead, Regulatory Content Management (Hybrid)

Job Description

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:

• Responsible for the solution design and perform as lead delivery of Regulatory Affairs content management solutions in support of new business processes

• Work with configuration teams to design content management solutions

• Manage engagements and delivery for master data management in support of Regulatory content management business Processes

• Work directly with business to derive new solutions in support of agile based sprint releases

• Integration owner for all content management integrations within the regulatory source content management solutions

• Work directly with Regulatory solution architects to confirm standards and work to ensure all integration standards are met

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

• Help to maintain system backlog and evaluate backlog items for future execution

• 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 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 7 years or equivalent with large scale validated scientific computer systems.

• Minimum of 5 years of engineering and solution delivery with GxP systems.

• Experience with OpenText Documentum and D2 configurations, Veeva Vault RIM.

• 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 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.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

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):

Requisition ID:R254250