Description North America Director of Regulatory Affairs & SafetyLife Sciences
With relationships with 27 out of Top 30 Global Pharma, Cognizant are recognized as an ITO & BPO partner across all areas of the Life Sciences value chain. The Life Sciences vertical comprises over 10,000 associates delivering solutions across US, UK, Europe, India, China and Japan. As a full-service provider, Cognizant provide strategy consulting, package implementation, application development, and maintenance as well as infrastructure and BPO services. Our consulting services include strategy, business-/IT alignment, packages, requirements management, and process consulting with a dedicated Life Sciences Consulting team of over 100 associates. Specific areas of focus in R&D include Clinical, Regulatory, Safety & PV Operations.
Cognizant Life Sciences Solutions Group has been a leader in R&D services for 15 years. We work with the world's leading organizations to provide collaborative solutions to their business and IT challenges with innovative ideas that are embraced by their customers. More than 5,300 professionals around the world leverage deep industry knowledge across 15 verticals including: banking and financial services, healthcare, life sciences, retail, consumer goods and insurance to deliver robust digital solutions in key areas of client growth.
Our Life Sciences R&D team is growing at a record pace to deliver end-to-end technology consulting services to Pharma, Device and Vaccine Discovery and Development. We are looking for seasoned consultants with industry experience to strengthen our team and help us exponentially grow our services business in Life Sciences R&D. Location: remoteSummary:
Work with clients in the Clinical Services space to help them transform their Business landscape. As North America Director of Regulatory Affairs, Safety & PV Centers of Excellence, you would be responsible for:Responsibilities:
- Assume P&L responsibility for Regulatory & Safety/PV Services Centre of Excellence
- Take up annual growth targets for top line and bottom line
- Identify, establish and manage partnerships with lines of services and with the CoE
- Work with CoE teams to develop new service offerings and accelerators
- Create joint GTMs with partners and setup growth targets with partners
- Deliver thought leadership in areas like touchless case processing, automation in Safety & PV etc.
- Develop proposals to proactively pitch Cognizant R&D capabilities
- Respond to RFI, RFPs
- Help fulfil staffing needs for clients, as needed
- Represent COE in Industry Forums, prepare and publish thought leadership PoV pieces and white papers on key topics impacting the Industry
- Prepare and spearhead marketing campaigns - both internal and with clients
- Past experience in handling P&L for IT consulting services
- Experience with products like Vault RIM, Argus Safety, ARISg, Empirica, Generis CARA, Liquent, ISI etc.
- Proven IT consulting experience in the industry, a significant amount of which should have been spent on developing new business and managing customer relationships
- Proven track record in growing accounts from existing business
- Good understanding of the Life Sciences R&D domain, with 10 years operating in this area
- Customer orientated and ability to keep on top of all progress and potential risks across the engagement and client landscape
- Knowledge and experience in delivering solutions and services with 21CFR Part 11/GxP compliance
- Experience working for an IT consulting organization with sales experience in Life Sciences R&D
- Excellent understanding of end-to-end Regulatory Affairs, Safety & PV processes
- Experience managing partnerships with Aris Global, Veeva, Oracle etc.
- Must have worked with offshore based teams in Eastern Europe, India and other locations
- Credible client engagement skills - across all levels with Client organization
- Strong leadership skills
- Excellent communication and inter-personal skills are critical
- Highly organized and effective communicator
- Reliable and dependable
- Natural ability to build customer rapport
- Self-motivation and ambition
- Analytical and able to assimilate information quickly
- Proven ability to develop and close business opportunities