HomeRegulatory AffairsAssoc. Director Regional BPIM (Regulatory Operations) | MSD Pharmaceuticals | Mumbai

Assoc. Director Regional BPIM (Regulatory Operations) | MSD Pharmaceuticals | Mumbai

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Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, the Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines, and animal health products.

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In a world of rapid innovation, we seek brave Inventors who want to make an impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Designation: Associate Director, Regional Business Process Information Management (BPIM) (Regulatory)

Location: Platina, Mumbai, Maharashtra, India

Job Description:

THE OPPORTUNITY

  • Implementation of Regional Business Process Information Management that aligns with business imperatives in Regulatory Affairs
  • Based in Singapore, the regional hub for Asia Pacific (AP) and named one of the Best Companies to Work for in 2019 by HR Asia
  • Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.

WHAT YOU WILL DO

The Associate Director, Regional Business Process and Information Management (BPIM) will be the lead for the regional activities associated with the implementation and support of the GRACS Information Management (IM) Strategy projects and systems.  You will play a critical role to connect the activities of the BPIM group in our Company’s Headquarters to the users in the regional hubs and out to the Country RA groups in the specific region in which they work from the three major GRACS regions (Latin America: Europe, Middle East and Africa; Asia Pacific).  They will ensure that regional needs are understood and translated into the requirements for the system and are communicated within the project team, both to the global team members but also back to the region and country RA. They will also ensure that tasks within the global project that require regional input are successfully completed.  You will represent their region in the global project activities and lead the regional team in managing and completing the regional tasks.  When a particular change only affects the region this person works in, they will be responsible for leading the overall team and meeting the project objectives and deliverables.  You may also be involved in regional projects that support the local business and regulatory strategy where their skill set and experience in leading and working in teams looking at change management and business process development can be used.

You will generally focus on one or two projects at any one time across the GRACS Information Strategy portfolio (current priorities include content management for regulatory submissions; submission planning tools and processes; regulatory information management systems for product information and registration management) but may need to provide support or information across other projects on an as needed basis.  On occasions, you may take on roles and tasks as part of the global implementation project team for a specific project.  The ability to prioritize their workload and work to deliver the objectives of their projects will be a key marker of success in this role. You will also be responsible for the following :

  • Lead and manage the regional input to global IM Strategy projects, in agreement with the global project leads.  As needed, work with colleagues from RAI, Regional CMC and other GRACS subfunctions to establish subteams to deliver the regional objectives and deliverables
  • Lead and manage regional IM Strategy projects.  As needed, work with colleagues from RAI, Regional CMC, and other GRACS subfunctions to establish teams to deliver the objectives and deliverables
  • Lead and manage the development of business processes and change management initiatives associated with IM Strategy projects.  They may lead or be involved in regional business process projects.
  • Provide and manage regional input to the GRACS IM Strategy, ensuring that the IM Strategy evolves with the regional needs and landscape.  Understanding changes in the external environment that affect the IM strategy.
  • Enable efficient processes and clear communication for IM Strategy projects by collaborating with Reg Ops HQ staff in BPIM and regional and country RA staff in the main GRACS Regions
  • Provide strong, cross-functional team leadership in a virtual environment for IM Strategy projects within the region and manage senior leader interactions and collaborations (team size typically 5-10 people)
  • Report on progress on delivery of regional objectives to Regional Management, Project team Leads and other Senior Managers as required.
  • Collaborate with other Regional BPIM staff to align activities, share best practices and ensure the efficient completion of future projects
  • As agreed with regional leaders and global project leaders, perform  global roles within IM Strategy projects
  • As needed, organize and oversee the work of the contract and sourced resources who are allocated by the International Reg Ops group and Regional Reg Ops Lead to support IM Strategy project work in the region

WHAT YOU MUST HAVE

To be successful in this role, you will have:

  • Bachelor’s degree in a science or information technology discipline required
  • Min of 5-8 years’ experience in Regulatory Affairs and/or Regulatory Operations, with at least 3 years’ experience in implementing and/or supporting regulatory information systems (e.g. document management systems such as Documentum or Veeva, submission publishing tools such as eCTDXpress or InSight, regulatory information management tools such as InSight or ArisGlobal, etc.).
  • Good understanding of System Development Life Cycle methodology and the requirements for the validation of information management systems.
  • Demonstrated understanding of drug development and execution of regulatory program strategies within the countries making up the region and how this impacts regulatory IM strategies
  • Proven experience as a leader on cross-functional teams and able to influence and motivate team members and Senior Management leading to high quality and on-time delivery of project objectives.
  • Demonstrated situational leadership and creative problem solving within organizations and teams
  • Ability to prioritize their own work across several ongoing projects
  • Ability to lead by influence and work effectively in matrix organizational structures
  • Ability to understand details, but keep the overall “big picture” view of projects
  • Expertise in project management methodologies (e.g. PMBok, Lean Six Sigma, Change Management, etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
  • Advanced degree preferred (engineering or scientific discipline, MBA)

WHAT YOU CAN EXPECT

  • Limitless opportunities across various areas within the Business.
  • You will be engaging with key stakeholders of the business in global projects to change management and business process development

Contact Details:

leena.wankhade@merck.com

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