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Job Details


Merck & Co, Inc

Associate Director, Technical Product Manager (Hybrid)

Science and Research

Laboratory Manager

No

West Point, Pennsylvania, United States

Job Description

Key tasks include:

  • Manage solution delivery of Vault Regulatory Information Management (VRIM) solutions across multiple configuration and Vendor releases.

  • Participate in software and systems design reviews to analyze regulatory processes and propose optimization of existing Veeva platform.

  • Oversee the product enhancements and defects and lead the weekly status meeting and compile a prioritized list of PE’s to send over to Veeva for annual analysis.

  • Provide technical review and approval assistance on all SDLC documentation for all VRIM releases (configuration + platform).

  • Organize priorities with integration team during bi-weekly integration status meetings.

  • Active member and/or participant on: CCB, weekly status meetings, Veeva CoP and weekend deployment activities.

  • Lead monthly meetings with the Veeva EAM.

  • Active participant in all VRIM configuration design reviews.

  • Working with the Robotic Process Automation (RPA) bot team to integrate with VRIM system to achieve process/technical efficiency.

  • Create and coordinate all Impact Assessment reviews for all of the Configuration releases.

  • Provide guidance to the AMS team during Veeva Platform releases.

  • Lead monthly meetings with Veeva EAM.

  • Primary point of contact with VRIM Veeva relationship and vendor management activities as capable.

  • Support the transition away from VRIM customizations.

  • Manage solution delivery of Vault Regulatory Information Management (VRIM) solutions across multiple configuration and Vendor releases

  • Participate in software and systems design reviews to analyze regulatory processes and propose optimization of existing Veeva platform

  • Oversee the product enhancements and defects and lead the weekly status meeting and compile a prioritized list of PE’s to send over to Veeva for annual analysis

  • Provide technical review and approval assistance on all SDLC documentation for all VRIM releases (configuration + platform)

  • Organize priorities with integration team during bi-weekly integration status meetings

  • Active participant in all VRIM configuration design reviews

  • Working with the Robotic Process Automation (RPA) bot team to integrate with VRIM system to achieve process/technical efficiency

  • Create and coordinate all Impact Assessment reviews for all of the Configuration releases

  • Provide guidance to the AMS team during Veeva Platform releases

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 5 years or experience with Veeva platform, especially in the Regulatory solutions

  • 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 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.

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 separationpackage, 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.

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.

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:

EEOC Know Your Rights

EEOC GINA 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.

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

na


Required Skills:

Benefits Administration, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management


Preferred Skills:

API Management, API Management, Business Case Development, Business Management, Clinical Medicine, Clinical Trials, Cloud Infrastructure, Collaborative Development, Computer Engineering, Computer Science, Customer Experience Management, Customer Satisfaction, Customer Service Management, Delivery Management, FDA Regulations, NICE Robotic Process Automation (RPA), Organizational Behavior, Performance Management Tool, Presentations, Process Engineering, Project Architecture, Quality Management, Relationship Management, SAP Project Management, Service Oriented Architecture (SOA) {+ 3 more}

Requisition ID:R272097