Job Description: Summary
You will work within the Product Management team on Regulatory Information Management (RIM) solutions from conception to launch. As part of the product management team, you bridge the technical and business worlds as you design products that our customers love. You will closely work with other SMEs within the company to develop product roadmap. You will provide subject matter expertise to align product roadmap with customer needs and agency guidance. You will also provide support to sales and marketing initiatives, as needed. You have a bias toward action and can break down complex problems into steps that drive product development. As a subject matter expert, you will be part of shaping the next generation of RIM solutions.
Serve as a product manager in regulatory technology solutions team.
Own roadmap for certain products in the regulatory technology solutions space. Define product vision and strategy. Formulate and define product scope and objectives based on industry needs and agency guidance.
Gather and document requirements from regulatory compliance and client need standpoint. Prioritize requirements/features with inputs from key stakeholders.
Perform analysis of business needs, documentation of requirements and translation into proper user and functional requirement specifications. Perform analysis of requirement updates - identifying technical and business impacts to ensure effective decision making.
Own user interface design, ensuring consistency of technology and implementation across modules.
Help facilitate the implementation and maintenance of a more Agile development process
Mentor, instruct and direct the work of other business systems analysts.
Utilize issue tracking system and change control processes and systems to ensure that the development backlog is maintained.
Work with the development and QA team members to ensure that product updates are delivered on time and in accordance with the product roadmap.
Support pre-sales and sales process, by providing RFP input or conducting client demo.
Project Management responsibilities to ensure the effective, on-time, delivery of IQVIA product.
Minimum of a Bachelor's degree and/or relevant certifications.
7+ years of relevant experience working with life-sciences companies (e.g. Regulatory Affairs, Clinical, Medical Information) with a demonstrated understanding of drug development processes and technologies
Experience with eliciting and drafting use cases and business/user requirements.
Effective leadership and communication skills.
Nice to have:
M.S. or PhD. in a scientific field or MBA Degree.
3+ years of RIM-oriented products and services or a combination of 5+ years regulatory and/or related experience.
Detailed understanding of emerging regulatory industry best practices, trends, and/or standards including eCTD, IDMP, xEVMPD, etc.
Direct experience implementing /consulting on known regulatory technologies - e.g. Vault RIM, Open Text, DXC FirstDoc, Acuta, Extedo, Amplexor and/or Paraxel Liquent
Execution experience with Agile methodology and/or ACP Certification
Experience of RIM systems is a distinct advantage; IDMP, XEVMPD, Registration Tracking, Medical Device RIM requirements, etc
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at email@example.com to arrange for such an accommodation.
Iqvia Holdings Inc