US Citizen
Green Card
EAD (OPT/CPT/GC/H4)
H1B Work Permit
Corp-Corp
W2-Permanent
W2-Contract
Contract to Hire
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 10th Feb 2024
• Have a proven track record leading discussions with senior management and executives as the subject matter expert.
• 10+ years of experience designing and delivering Clinical and Regulatory GxP and non-GxP IT solutions.
• Extensive Veeva Development Cloud background and demonstrated understanding of the key processes and sub-processes specific to Life Sciences.
• Strong understanding of system and data security principles and best practices.
• Willingness to "wear any hat" that is necessary to drive customer success.
• Continue to extend subject matter expertise in the life sciences industry and learn Veeva Solutions.
• Strong understanding of system and data security principles and best practices.
• Good functional knowledge of Life Sciences Market Authorization processes.
• Ability to communicate efficiently with technical and non-technical staff and members of interdisciplinary teams both verbally and in writing.
• Keen attention to detail and proven analytical and problem-solving abilities.
• Ability to handle multiple priorities and work under pressure.
• Excellent problem-solving skills.
• The following Qualifications are Required:
o Expertise in Veeva RIM, Veeva Submissions, Archive, Veeva QMS, Veeva Quality Docs ·
• The following Qualifications are preferred:
o Experience with Regulatory Affairs Strategy, Intelligence, Regulatory Information Mgt & Operations, and/or Submission Publishing domains in support of market authorization.
o Experience with Audits, Inspections, Vendor Oversight, and issues management such as SSNs. CAPA, and risk management.
o Experience with Architecture Frameworks/Processes (e.g. TOGAF) and help define patterns and other architectural accelerators.
Education & Certifications
• Bachelor's Degree
Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.