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Senior Regulatory Affairs Specialist

2 months ago

New York, New York, United States Innova Solutions Full time

Innova Solutions is currently seeking a Senior Regulatory Affairs Specialist.

Position Type: Full-time; Contract

Duration: 12+ Months

Location: Remote

Compensation: $35 - $39/hr on W2

Role Overview:

As a Senior Regulatory Affairs Specialist, you will play a crucial role in supporting our ongoing projects. We are looking for a candidate who is adept at learning new systems, has experience managing content in SharePoint, and possesses a solid understanding of Six Sigma methodology, process mapping, and project management.

Key Responsibilities:

  • Adapt to new systems and processes effectively.
  • Assist in the implementation of regulatory initiatives such as Veeva Vault, IDMP, and EU CTR.
  • Collaborate with stakeholders to gather requirements and develop tailored solutions.
  • Provide expertise in Veeva Vault configuration and regulatory processes to a global audience.
  • Create and deliver training materials and presentations for a diverse audience.
  • Author, review, and approve essential Regulatory Information Management & Systems documentation.
  • Analyze existing documentation and processes to identify opportunities for simplification and enhancement.
  • Offer operational support for Regulatory Data Management and submissions.
  • Develop and implement process improvements and automation strategies.
  • Lead or support team projects as necessary.
  • Organize and present data in user-friendly formats that illustrate performance metrics and facilitate business improvement.
  • Utilize Six Sigma methodologies to enhance team processes.

Qualifications:

  • Master's degree OR Bachelor's degree with 2 years of relevant experience OR Associate degree with 6 years of experience OR High school diploma/GED with 8 years of experience.

Essential Skills:

  • Strong communication skills (both verbal and written).
  • Resourceful critical thinking abilities.
  • Experience in process mapping with a focus on detail and data quality.
  • Understanding of regulatory affairs is highly preferred.
  • Regulatory certifications (RAC) are advantageous.
  • Interest in technical systems, such as SQL, will also be considered.

Work Environment:

This position is fully remote, and candidates should be available to work standard hours, preferably within the EST time zone. Flexibility to adjust hours for additional support in the PST time zone may be required.

About Innova Solutions: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. We deliver strategic technology and business transformation solutions to our clients, enabling them to excel in their respective fields.

Benefits: Innova Solutions offers a range of benefits based on eligibility, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings accounts, life insurance, and various types of paid leave.

Innova Solutions is an Equal Opportunity Employer and is committed to providing a work environment free of discrimination and harassment.