Product Manager - Regulatory Affairs

Company: MSD Malaysia
Location: Rahway
Posted on: May 28, 2023

Job Description:

Product Manager - Regulatory Affairs page is loaded Product Manager - Regulatory Affairs Apply locations USA - Pennsylvania - North Wales (Upper Gwynedd) USA - New Jersey - Rahway CZE - Central Bohemian - Prague (Five) USA - Pennsylvania - West Point CZE - Central Bohemian - Prague (IT Riverview) time type Full time posted on Posted Yesterday job requisition id R239954 Job DescriptionProduct Manager Regulatory Affairs The Information Technology team at our Company's Research and Development division is seeking a Product Manager - Regulatory Affairs Submission Authoring and Source Content reporting into the Regulatory Product Line Lead. This position will be responsible for managing the development and implementation of content-based strategies, processes, and systems while ensuring compliance with regulatory requirements and maintaining high-quality standards. - 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 be more productive while enabling innovation.This role is to establish an appreciation of current end to end solutions in our Research & Development Division's IT Regulatory Affairs Submissions process environment and establish the future technical design for said environments, enable software platforms, data, and analytical needs 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 Authoring and Source Content capabilities. -Key tasks include:

• Accountable for the solution design and delivery of Regulatory Affairs systems.
• 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 GxP and our Company Systems Development Lifecycle 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.Skills :
  • Has the ability to be self-motivated to comprehend current regulatory business needs and current architecture, platforms, and systems.
  • Demonstrated partnership working with matrixed IT and client organizations to drive highest value business outcomes aligned to business and future state technology strategies.
  • History of developing strong relationships with key vendors to influence vendor's strategic roadmaps and provide transparency around platform roadmaps.
  • Knowledge and experience with Agile Application development, testing and implementation in external hosting and cloud environments.
  • Ability for envisioning architectural scheme, information structure and features, functionality, and user-interface designs; leverages current best practices in cloud-based design and development.
  • Worked with cloud-based architecture which includes AWS, Microsoft Azure (Azure File Sync), data storage and analytical reporting as part of a corporate environment.
  • Implements design by preparing technical write-ups and interactive prototypes and mockups.
  • Has supported and worked with validated health authority regulatory capabilities.
  • Strong knowledge of System Development Lifecycle within a GxP environment and participation in system audits and inspections (internal/external)
  • Ability to manage a high performing team providing career development and support for future career paths.
  • -Demonstrated partnership working with matrixed IT and client organizations to drive highest value business outcomes aligned to business and future state technology strategies.
  • Worked with submission authoring and source content tools and applications supporting regulatory submissions. The technologies include:
    • OpenText
    • Veeva Vault
    • SharePoint
    • AWS and Azure Cloud TechnologiesMinimum Education:
      • B.A./B.S. in Computer Science, Engineering, MIS, and Science or in a related fieldPrerequisites:
        • Minimum 10 years with large scale validated scientific computer systems.
        • Minimum of 5 years of engineering and solution delivery with GxP systems
        • Demonstrated ability to analyze and define business problems and identify appropriate technology solution(s)
        • Strong understanding of modern cloud architecture patterns as they relate to application development.
        • Understanding of customer journeys and customer experience, with reference to digital, design and services in pharmaceutical industry
        • Background that comprises both solid business understanding as well as technical understanding of high-quality digital product delivery
        • Knowledge of agile values, principles, and practices
        • Knowledge of the pharmaceutical industry
        • Strong leadership skills and the proven ability to drive organizational change
        • Strong teamwork and partnership skills
        • Drive for results augmented by strong planning and organization skills
        • Deliver customer value - dedicated to comprehending and meeting customer needs
        • Strong Communication skills for verbal, written, and technical presentations
        • Demonstrates ethics and integrity
        • Ability to lead and manage multiple teams across multiple projects.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 APPLICANTSIn 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.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. For more information about personal rights under Equal Employment Opportunity, 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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 . Learn more about your rights, including under California, Colorado and other US State Acts 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:RegularRelocation:No relocationVISA Sponsorship:No Travel Requirements: 10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:YesHazardous Material(s):N/A Similar Jobs (1) Container Product Owner locations 4 Locations time type Full time posted on Posted 13 Days Ago Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Keywords: MSD Malaysia, New York , Product Manager - Regulatory Affairs, Executive , Rahway, New York