IMS Health and Quintiles have come together to be IQVIA. We have created a new way to harness advances in technology, analytics and human ingenuity called Human Data Science, to deliver solutions that help our customers drive healthcare forward and help patients around the globe. Inspired by the industry we help, our employees are committed to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.
Post : Regulatory Affairs Associate
Job Description
PURPOSE
Assists in the preparation and/or review of regulatory documents and submissions. Serves as a regulatory member on project teams, under guidance of senior staff. Provides regulatory support for assigned projects.
RESPONSIBILITIES
• Creates an inventory of appropriate regulatory documents based on checklists prepared by Regulatory personnel.
• Identifies project needs, tracks project timelines and implements client requests, with senior review.
• Reviews documents for regulatory completeness, consistency and accuracy, interacts with project team members to assure completeness, as necessary.
• With oversight may draft text for straightforward regulatory documents, and conduct QC review of documents prepared by the regulatory unit, project team or client.
• Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff.
• May work independently with internal clients and may interact with external clients, under guidance of senior staff.
• Assists with project budget, project management, business development activities and other tasks as required by senior Regulatory team members.
• May address technical issues with documents and offer assistance to staff.
• Performs other tasks or assignments, as delegated by Regulatory management.
Candidate Profile
• Degree in life science-related discipline or professional equivalent
OR
• High school diploma plus at least 3-5 years experience
OR
• Combination of education, training and experience
AND
• Good, solid interpersonal communication (oral and written) and organization skills
• Strong software and computer skills, including MS Office applications
• Above average attention to detail and accuracy
• Working knowledge of regulations and guidances relevant to the area of expertise
• Ability to work on multiple projects, with direction from senior staff as appropriate
• Ability to adapt quickly to a rapidly changing environment
• Ability to follow SOPs consistently
• Ability to make decisions on discrete tasks under senior supervision
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
Additional Information:
Location: United States
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
End Date: 25th April, 2018
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