Regulatory Product Line Technical Lead

Job Description

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We partner internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

We are looking for a seasoned professional with a strong software development and cloud computing background to help us shape the technical vision and strategy of our software products. This role is to establish an appreciation of current end to end our Research & Development Division's IT Regulatory Affairs Submissions process environment, establish the future technical design for environments, software platforms, data and analytical needs to enable to meet or surpass business and IT needs. In addition, the ability to quickly achieve a clear understanding on how things are currently designed, developed and implemented across the regulatory systems landscape. This will ultimately allow this role to establish and execute on strategy and plans to enable best-in-class IT solutions for Regulatory Affairs Submission capabilities. As our Research & Development Division IT continues the transition from project / portfolio-based execution to the product model, it is important to have an experienced leaders dedicated to this important capability.

Responsibilities

As the Regulatory Product Line Technical Lead you will spend a lot of time helping shape, implement and support the technical vision and strategy of the Product Line. This requires discussions and consciously driving decisions in the right direction. This applies both internally to the team and externally to business and technical stakeholders of our system. You will work side by side with Product Manager, Solution Architect and other Technical Leads and be accountable for the entire product lifecycle.

Being a non-authoritative leader towards the team and a strong partner to business stakeholders are the right skills for this. Additionally, you'll be responsible for guiding other teams to negotiate and align the technical strategies and adjust their solutions to the strategic architectural concepts.

We will also need you to share your knowledge with us and help other team-members grow their technical knowledge and expertise, especially in design and architecture of robust solutions. We do have a skill gap in this area, and we want to learn those skills from someone who has the experience we do not have.

Additional Responsibilities Include

• Managing Technology Vendors for the product

• Providing technical oversight for internal and external support organizations

• Ensuring proper Root Cause Analysis (RCA) is being performed

• Estimate complexity for different technical solutions do define the product roadmap, which is technically feasible and achievable

Position Qualifications

Education Minimum Requirement:

• Bachelor’s degree in computer science or a related quantitative field

General Experience and Skills:

• Minimum 5 years of experience as a Solution Architect, Software Engineer, Support Engineer or similar role

• Experience working in the product model

• Excellent English and ability to explain complex technical topics to both technical and business audiences

• System analysis and design experience in scalable applications

• Experience with DevOps automation in software engineering

• In-depth understanding of database structure principles, SQL and NoSQL concepts

• Software engineering and programming background

• Experience supporting global systems

• Experience in software validation, testing and release management

• Strong technical leadership and vendor management skills

• Great organization skills with the ability to manage competing priorities

• Self-driven with the ability to work in a self-guided manner

• Strong problem-solving skills

• Prior experience in the pharmaceutical industry.

• Experience with GxP validations

• Experience with System Development Lifecycle (SDLC)

• Experience with Regulatory solutions that use Microsoft Project Server, Appian, Veeva, Calyx RIM, OpenText Content Management, Azure and AWS Cloud Technologies is a plus.

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., Rahway, 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.

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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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Expected salary range:

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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:

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Flexible Work Arrangements:

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Requisition ID:R239364