IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
ACUTA, an IQVIA company, was founded in Nov 2012 as a technology company, providing Regulatory Information Management (RIM) solutions and services to the Life Sciences and related industry. ACUTA is focused on three strategic lines of business that include Integrated Regulatory Solutions, Business Process Consulting and Technology. Our offerings combine very knowledgeable people, process and technology to provide complete RIM capabilities to our valued customers. As regulatory standards emerge (and change) we continue to evolve our offerings and provide innovative and cost-effective solutions to the life sciences industry.
In this important role, you will work closely with the Product Manager on the identification, documentation and implementation of new requirements. Your knowledge of Regulatory Information processes will be as valuable as a proven ability to communicate effective requirements and help drive the implementation of the final solution. You will be excited to be involved in the shaping of market leading solutions that meet the current challenges of our clients and potential clients.
Please note, a large part of this role is dealing with our team based in India, which means that aligning on time zones as much as possible / is reasonable will be an important aspect to consider, if you would like to apply. However, we are flexible about where you are based;
The best US location would be the Marlborough, MA office or Philadelphia (Bensalem) office, or home-based on the East Coast.
The best UK position would be home-based, with easy access to the Reading, Berks office.
What a typical day looks like
- Participate in detailed requirement discussions related to Regulatory processes addressing areas such as Submission Publishing, Registration Tracking, Labelling and IDMP submissions.
- Document detailed User Requirements and contribute to the Functional and Technical Requirements to be implemented by Product Development and Quality Control teams.
- Contribute to the prioritization of requirements based on both external and internal feedback.
- Where necessary, manage the creation of conceptual prototypes and mock-ups.
- Develop & implement processes to drive collaboration between, quality and product development.
- Participate in development reveals on new features and provide internal and external awareness of the impact of those features.
- Help manage the release process of updated product.
Depending upon the skills and experience of the individual, additional responsibilities may include:
- Subject matter ownership of various regulatory domains.
- Ownership of the User interface design, ensuring consistency of technology and implementation across modules.
- Prototype development as needed with key teams.
- Ownership of the RIM Smart database: identifying the impact of updates and ensuing effective implementation and migration.
- Project Management responsibilities to ensure the effective, on-time, delivery of product.
Our ideal candidate will have
- Extensive domain knowledge in Regulatory Information Management, with experience of regulatory submission and/or registration tracking processes.
- An understanding of XEVMPD, and/or IDMP is preferred.
- Extensive experience with Regulatory Information Management software solutions and services, and an enthusiasm for improving software solutions.
- The ability to define both high level business requirements and detailed functional requirement documentation. This would include feature descriptions, mock-ups, and process diagrams.
- Strong business analysis skills - to ensure that the impacts of a product update are understood across the product for both development and QC.
- Effective written and verbal communication skills, to ensure a good day to day relationship is achieved with Development and QC.
- Ability to work with different people across a team effectively.
- Bachelor's degree required (MBA or other Masters preferred) and substantial experience related to the required skill set.
- Experience with modelling and user interface mock-up techniques would be an advantage.
- Ability to work as a single contributor with potential growth for potential leadership role.
- Project Management experience in an Agile development environment would desirable.
IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximise their personal potential.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Job ID: R1099948