Product Manager - PDMA Sampling and Compliance - New York Hub at Veeva
| Greater NYC Area
Sorry, this job was removed at 6:34 a.m. (EST) on Saturday, March 13, 2021
Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.
Veeva is looking for a high energy, creative individual with experience in PDMA and Sample Management to join our growing CRM Product team. You will be directly responsible for driving innovation and design features within our Sample Management functionality while ensuring our application remains compliant with relevant industry regulations. You will be the sampling expert working closely with customers, service teams, and product development to translate customer needs into product capabilities while helping define the roadmap and ensuring customer success.
If you have a passion for creating world-class products and enjoy solving complex problems with simple, elegant solutions, this role could be the one for you.
What You’ll Do
- Be the Sampling and Compliance subject matter expert both internally and with customers
- Cultivate the sampling roadmap by providing customer and user perspective on the product vision
- Work collaboratively with product development teams to design and deliver product capabilities that meet customer and market requirements
- Author high-quality specifications and communicate specific, actionable requirements to our engineering and quality teams
- Ensure system compliance with applicable regulations and that all testing is executed and documented according to Standard Operating Procedures and associated processes
- Manage the validation process cycle including scope planning, test plan and script review, and end to end resolution cycle
- Proven deep knowledge of 21 CFR Part 11 and PDMA
- Direct experience with computer systems validation within the pharmaceutical industry
- Curiosity for understanding how things work and asking the right questions to figure it out
- Advanced knowledge of requirements engineering, test environments, protocol development, and functional risk assessment
- Excellent verbal and written communication with the ability to present complex design concepts into clear and concise requirements
- Self-motivated, resourceful, and independent, willing to go the extra mile to make our product and customers successful
Nice to Have
- Experience with SaaS based solutions, especially Salesforce.com
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.