Digital Product Analyst -Global Complaints Management Digital Operations

Job Description

This position is within our Digital Manufacturing Division - Digital Quality Operations -Investigations Product Line Team. The Investigations Product Line Team is responsible for design, implementation, and maintenance of Digital Operations of the key QMS Processes -Deviations, CAPA, Complaints, Product Security Investigations, and Complaint Trending for Global Operations.

The Digital Product Analyst - Sr. Specialist will provide close support to the Product Complaints Reporting and Management Digital QMS Operations. This role supports the implementation, continuous improvement, and expansion of drugs, biologics and device requirement (Clinical and Commercial) related to the Complaint Management Program for processing and trending complaints. This role is responsible for leading teams to releasing products that meets the business' needs to achieve the team goals. You will also have end-to-end responsibility for defining and prioritizing requirements (stories) in the backlog and also accepting requirements (stories) as completed. In this role, you will work with stakeholders to uncover and communicate user needs and assist in Digital Product discovery activities. You will be instrumental in planning, designing, conducting testing activities, and engaging support teams for GxP products. You will be responsible for compiling critical content for business user training, work instructions, and communication for end users. You will closely work with teams like AMS and the Platform team to help sustain the production system. The incumbent is expected to work collaboratively with stakeholders across the global Product Complaints, Intake and Adverse Events business & Digital Operations landscape.

Primary Responsibilities:

• Provides subject matter expertise, independent perspectives, new ideas, thought partnership, education, upskilling, tools, and execution support to new opportunities. Collaborates with both business and value team stakeholders and operates as a trusted advisor and partner to drive successful identification of opportunities and associated business cases. Supports the Product teams so that what gets built is both valuable and viable for GxP use.

• Leverages business and user insight to help inform solutioning ideas and prioritization decisions to deliver valuable products. Has knowledge of and leverages existing solutions to benefit their stakeholders through using IT communities. Introduces and inspires change at all stages of product development.

• Applies a structured, agile approach to discover, document, and manage business process and stakeholder needs. Gathers insights into user stories, journey, behavior, motivation, unarticulated problems, unmet needs, use cases, user experience, and pain points.

• Coordinates the releases from planning to deployment ensuring high quality, on-schedule, GxP releases meeting the Quality business demand.

• Develops and maintains strong relationships with leadership and stakeholders to achieve key objectives and deliverables through building relationships and credibility within the organization.

• Gathers insight into user journey, behavior, motivation, and pain points. Exposes unarticulated problems and unmet needs.

• Documents business process, business and user needs in the form of problem statements to make up the backlog. Facilitates the "how" with the Engineering team.

• Supports technical solutions to enable functional/process transformation, content and medical information management, scientific publications, engagement and real-world evidence generation.

• Protects the live environment and its services through the use of formal procedures and check. Prioritize the contents of each release. Understands the complex dependencies, and tracking delivery as they meet the integrated delivery targets.

• Works with AMS teams when required to troubleshoot issues.

• Works with Veeva Platform teams on enhancements and releases.

• Leads the product evolution of a customer-facing global quality complaint reporting tools, aligning it with business and regulatory requirements and the general rollout plans.

Education:

• Minimum of a B.A./B.S. in a scientific or technical discipline (such as computer science, engineering, biology, chemistry, etc.). Pharmaceutical experience preferred.

Required Experience and Skills:

• Experience working with the Veeva QMS Platform & general experience in leading projects, leveraging web-based development technologies, APIs and automation.

• Understanding and familiarity with End to End Clinical and Commercial Pharmaceutical Product Complaints processes including Intake, Triage, Investigation, CAPA, Trending, association with Adverse Events and Safety and Pharmacovigilance Operations.

• 5+ years' experience working in related IT and/or Automation experience in pharmaceutical manufacturing or similar area.

• Experience in IT and in business process design.

• Experience with user experience design, research and data driven decision making on products to unlock customer value.

• Able to define product roadmaps and lead roadmap discussions with various stakeholders communicating the results to the technical teams.

• Experience in defining requirements, translating them between the development and business facing teams, and documenting them for GxP systems.

• Open and receptive to listening. Asks thoughtful questions. Curious and persistent. Able to discern pain points and simplify complex problems.

• Critical thinker who can effectively balance the needs of stakeholders and users. Embraces new ideas and evidence and fosters a collaborative atmosphere.

• Curious and persistent, able to discern pain points, simplify complex problems, conducting root cause analysis and identifying recommendations for improvements.

• Well organized and adaptable to unstructured situations. Comfortable in all SDLC phases where projects are conceptualized, issues discussed/ resolved, and business cases are developed for a global launch.

• Working knowledge of Waterfall, Hybrid, Agile/Iterative methodologies and tools (e.g., Jira, ALM, Mural board)

• Experience in program management.

• Experience with (domain area) enterprise implementations.

• Strong understanding of modern architecture patterns

• Experience with digital technologies such as artificial intelligence, IoT, data analytics, automation, as well as cross discipline in Application development and Business Intelligence, Analytics, support, engineering, and architecture.

• Self-motivated, value-oriented with a mindset of continuous learning. Experience managing and motivating multiple teams; Excellent communication and presentation skills for a wide range of audiences.

• Understanding and familiarity with 21 CFR 210 and 211, ICH Guidelines, FDA Guidance documents, Combination Product Regulations and Requirements

Preferred Experience and Skills:

• Able to adapt to rapidly changing technology and apply it to business needs.

• Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity at the center.

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.

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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".

Under New York State, 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:

$111,400.00 - $175,300.00

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

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

Preferred Skills:

Biological Sciences, Business Acumen, Business Case Development, Business Intelligence Implementation, Business Management, Business Process Development, Business Process Modeling, Collaborative Development, Complaint Resolutions, Computer Science, Digital Business Development, ICH Guidelines, Information Management, IT Business Management, IT Project Lifecycle, Market Opportunities, Pharmacovigilance, Presentations, Prioritization, Process Improvements, Production Processes, Product Roadmapping, Program Management, Quality Management, Strategic Thinking

Requisition ID:R279240

PDN-9b3e8e04-fe63-4f8d-822b-146b27c96636