At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.
The Regulatory Intelligence Manager will work on the creation and maintenance of a global database of regulatory and guidance documents for the startup and conduct of clinical trials. You will identify and collect clinical trial application regulations and requirements. You also will be the go-to contact for our professional services teams helping clients to incorporate that intelligence into their implementations. The successful candidate will also help develop tools to assist our customers and internal teams as they review and adopt our regulatory intelligence.
What You'll Do
- Monitor global government regulatory agencies, IRB’s, and ethics committees to capture their documentation requirements and review periods for clinical trial applications and other key in-study events.
- Translate regulatory guidelines and timetables into Vault’s framework for use within our Clinical suite.
- Incorporate the above regulatory processes and requirements into broader clinical operational processes and product features across the Vault Clinical suite.
- Coordinate with regional and functional Market Owners and Product Manager to identify gaps and/or new opportunities to collect regulatory intelligence, and to develop strategies and tactics for doing so.
- Proactively summarize and communicate important regulatory changes to Vault’s product, commercial, and services teams to better support Vault clients.
- Work with Product Management to define and improve the processes and tools for collecting, managing, and socializing regulatory intelligence, and to develop new processes and tools as the need arises.
- 3+ years experience in one or more of the following industries and roles: commercial software (ex. product management, consulting, solutions consulting, customer service and success), clinical development and life sciences (ex. clinical operations, regulatory affairs), commercial content management and market research (ex. serving sectors such as life sciences, consumer products, retail, finance, etc)
- Working knowledge of clinical research site processes and procedures.
- Self-motivation and attention to detail
- Creativity and problem solving, along with strong internet research skills
- Excellent communication skills: written, verbal and formal presentation
- Experience interacting with customers, product, and services teams, both local and remote.
- Comfortable working with a controlled system for the collection, review, and management of documents and other data.
- Excellent working skills with office software (ex. MS Office; Google Suite)
- The position is remote, with a preference for candidates proximate to one of Veeva’s offices in Radnor, PA, or Princeton, NJ
- Willingness to travel occasionally to Veeva offices (including headquarters in Pleasanton, CA) and/or to customer sites
Nice to Have
- Direct experience in the clinical development space in one of the following sectors: pharma/biotech/medical device; regulatory agency; contract services provider to the clinical space
- Experience with enterprise content management (documenting sources; SOPs for collecting; data governance)
- Some basic scripting skills for working with and transforming data (ex. Python, R)
Perks & Benefits
- Flexible PTO
- Allocations for continuous learning & development
- Health & wellness programs
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.