Regualtory Specialist II supports a team in the preparation and maintenance of complete and accurate regulatory documents in support of clinical research studies
Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry CDISC and regulatory compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.
Professionals having proven competency and success in conducting Quality Assurance and / or managing studies under GLP (Good Laboratory Practice environment, with at least 10 years of post- qualification experience, and should possess M.Sc./ M.V.Sc. / M.Pharm / M. Tech qualification.
Post Graduation in Science M.Pharm, Life Sciences, Biotech, Zoology, Botany, etc. PG Diploma in Clinical Research is mandatory with one year experience is desirable.
Exercising excellent interpersonal communication skills to effectively and professionally liaise with the internal teams, healthcare professionals, and other key stakeholders