Regulatory Consulting Manager+ Job Listing at Accenture in Wayne, PA (Job ID 00214117)
Consulting, Business Development/Sales
• Minimum of 10 years combined Pharmaceutical, Biotech Consulting experience
• Minimum of 5 years Regulatory Affairs/Regulatory Operations experience
• Bachelor’s degree
• Experience with leading industry tools such as Documentum, LiveLink, Insight Product Suite eCTDXPress
• Exposure to all phases of a Regulatory document management and/or publishing system implementation including requirements gathering, development, deployment support
• Experience in producing Regulatory submissions including CTDs eCTDs
• Proven success in service delivery experience
• Extensive experience working directly with Pharma and/or Bioipharm RD executives
• Implementing systems experience in a validated environment
• Familiar with 21 CFR Part 11
• Experience in producing electronic submissions including eNDAs, eBLAs, eANDAs, eINDs and/or eCTDs
• Ability to manage several tasks simultaneously
• Strong writing, oral presentation skills
• Experienced team leader and mentor
• Skilled in managing tasks and teams across multiple projects
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Accenture is an Equal Opportunity Employer.
Accenture is committed to providing veteran employment opportunities to our service men and women.
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