Senior Practice Lead Regulatory Analyst (SME) Job
Job Description Job Attributes+
Plymouth Meeting, PA, US
Business Consulting, Strategy and Digital Transformation
CGI is recruiting a Senior Regulatory Analyst /Subject Matter Expert to join our growing Life Science Practice. This person will be responsible for all regulatory functions related to new markets and acquisitions.
Candidate can reside in PA or NJ with light travel to surrounding areas.
• 10+ years of related experience in compliance privacy and/or regulatory affairs and/or submissions
• Can come from a Clinical or Drug Safety area as well, as long as there is a strong background on the regulatory side
• Technology “prowess" – understanding the functionality of the latest technologies
• Ability to understand the client’s needs, i.e. “I’ve walked in your shoes!"
• Consulting experience is a big plus!
• Experience in project management with working knowledge of laws and/or regulations in area of compliance, in particular HIPAA, and state regulations
Light travel will be involved – especially in the tri-state area.
DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED
• Fluency in English, additional languages are desirable
• Innovative thinker
• Proven ability to work cross-functionally and cross-regionally across multiple business units
• Excellent presentation, facilitation and communication skills, both written and oral
•Well organized, highly motivated, process driven and results oriented with the ability to prioritize and collaborate in a multi-tasking environment
#CGIPhillyMetro / #LI-ML1!
Day to day responsibilities will include 50-60% billable hours to a client that may include (but not limited to) Implementation, integration, migration process optimization, strategizing, navigating, planning etc… 40-50% of time will be working in front of clients doing “consulting" work – being a thought leader in the area of Pharmaceutical regulatory issues.
•Respond to external requests for information required by the organization for its regulatory filings
• Manage compliance reporting responsibilities and respond to inquiries from state and federal regulatory agencies
• Manage ethics and compliance projects or implementations
• Review and synthesize regulatory requirements and create policy and/or position statements
• Assist in managing annual code of conduct attestation and remediation
• Provide development guidance and assist in the identification, implementation, Assist in the identification, analysis, and resolution of compliance issues.
• Maintain and review regulatory documentation necessary to maintain corporate standards
• Assist in developing, producing and conducting compliance training programs
• Serve as a company-wide resource and liaison on policies, contract issues and provisions, communications, workflow, and quality improvements initiatives
- Analytical Thinking
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