Business Analyst - Veeva RIM, IDMP

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.

Position: Business Analyst - Veeva RIM, IDMP

Location: Hybrid - Chicago, IL

Type: Long Term Contract

Location: Hybrid - Chicago, IL - no flexibility (initially in office for a quarter, but potentially remote later)

Must Have's

• Veeva RIM, IDMP (Identification of Medicinal Products)
• Candidate must understand implementation of IDMP using Veeva RIM
• 10 years
• Regulatory/ Clinical domain
  
  

The Identification of Medicinal Products (IDMP) Business Analyst will hold an essential position in managing and leading the European rollout of the ISO Identification IDMP's standard within our Company. You will join a team advancing the strategic, project, and operational efforts related to regulatory data submitted to European authorities, encompassing IDMP/SPOR (European implementation of ISO IDMP), DADI (the substitute for the PDF electronic Application Form), and familiarity with XEVMPD (Extended EudraVigilance Medicinal Product Dictionary, or Article 57) is crucial for effectively transitioning to IDMP from both strategic and tactical viewpoints. You are also anticipated to address several non-EU related subjects.

Xevmpd

Primary Activities include but are not limited to:

• Engage, as needed, in the internal activities tied to the application of XEVMPD data within the EMEA.
• Utilize the understanding of data requirements and processes for the transition to IDMP.
  
  

Idmp

• Assist in formulating the IDMP strategy within our Company. Collaborate with colleagues throughout the Company to clarify the strategy and incorporate the needs and requirements from partner functions across Regulatory and various sections of the company.
• Aid in multiple projects aimed at implementing the IDMP strategy within our Company.
• Coordinate with the Business System Owner and IT counterparts, adhering to the principles of the System Development Life Cycle.
• Support the establishment and configuration of the IDMP Maintenance and Submission Tool, guarantee the accurate uploading of IDMP data into the tool, establish maintenance and submission methodologies with key stakeholders, and assist in the execution of operational tasks.
• Lead the Data Governance committee where cross-functional stakeholders work together to enhance internal data and systems in accordance with ISO IDMP and other internal use cases.
• Support the development of the internal Regulatory Data Hub to ensure it aligns with ISO IDMP concepts consistent with IDMP progress.
• Ensure coordination with IDMP-related subjects, including XEMVPD and the Digital Application Dataset Integration.
• Oversee non-EU IDMP-related initiatives.
• Communicate to the XEVMPD-IDMP Team Lead and Senior Management regarding the advancement of the IDMP program and projects.
  
  

External Activities

When the chance arises, represent our Company in European Industry Trade Association committees and meeting groups concerning IDMP. Assume leadership roles within the Trade Association committees and represent the industry in discussions and negotiations with health authorities and other stakeholders.

Qualifications, Skills And Experience

• A bachelor's degree in a science or information technology discipline is required.
• Extensive experience in Regulatory Affairs or Regulatory Operations.
• Hands-on knowledge and experience with ISO IDMP or IDMP/SPOR.
• A solid grasp of System Development Life Cycle methodology and the criteria for validating information management systems.
• Proven understanding of drug development and the execution of regulatory program strategies within countries and how this affects regulatory information management strategies.
• Experience as a leader on cross-functional teams, capable of influencing and motivating team members and Senior Management leading to high-quality and timely achievement of project goals.
• Evidence of situational leadership and innovative problem-solving within organizations and teams.
• Capability to prioritize personal responsibilities across multiple ongoing projects.
• Capability to lead through influence and collaborate effectively in matrix organizational frameworks.
• Capability to grasp details while maintaining an overarching "big picture" perspective of projects.
  
  

Desired Experience And Skills

• Strong knowledge of XEVMPD/Article 57, potentially with experience in implementing or assisting with reporting tools and processes.
• Proficiency in project management methodologies and related toolsets.
• Advanced degree preferred (engineering or scientific field, MBA).
  
  

If you are interested, please forward your resume to Amir@Net2Source.com.

Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.

Equal Employment Opportunity Statement

Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Awards And Accolades

• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
• Fastest 50 by NJ Biz (2020, 2019, 2020)
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)
  
  

Regards,

Amir Ahmad

Account Manager

Net2Source Inc.

Global HQ Address - 270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Fax: (201) 221-8131| Email: amir@net2source.com

Web: www.net2source.com | Social: Facebook | Twitter | LinkedIn