Mgr GRAAS Operations

Company: Innova
Location: Thousand Oaks
Posted on: March 6, 2025

Job Description:

Innova Solutions has a client that is immediately hiring Mgr GRAAS Operations. -

Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.

Position type: Fulltime - Contract - -
Duration: 12 months -
Location: 100% REMOTE -

As Mgr GRAAS Operations, you will: -

Job Description: The ideal candidate for this role is an experienced submission management professional with at least four years of hands-on experience in regulatory operations within the pharmaceutical or biotechnology industry. They should be a subject matter expert in eCTD publishing and submission assembly, comfortable with Veeva Vault RIM, and knowledgeable about submission content plans and validation publishing. Strong planning and timeline negotiation skills are essential, as this person will coordinate with cross-functional teams and manage vendor relationships to ensure timely submissions. The candidate should also be detail-oriented, capable of quality-checking vendor-published submissions, and flexible enough to step in for urgent publishing tasks when needed. Experience with DocuBridge or similar publishing tools is a plus. Minimum of 4 years of relevant experience is required. -

Roles & Responsibilities: -

• Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans
• Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
• Serve as primary point of contact between Client's functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system
• Independently remain current on guidance (internal/external) and translate requirements into operational activities
• Effectively represent global submission management expertise on key projects and global workstreams
• Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
• Represent departmental expertise on global work streams
• Initiate, lead and manage process development and improvement
• Lead information system and software update projects as well as ongoing system validations from a publishing perspective
• Provide technical support for regulatory systems
• Manage relationships with contributing functions and affiliates
  Basic Qualifications: -
  Doctorate degree -
  OR -
  Master's degree and 3 years of experience -
  OR -
  Bachelor's degree and 5 years of experience -
  OR -
  Associate's degree and 10 years of experience -
  OR -
  High school diploma / GED and 12 years of experience -
  In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above. -
  
  Qualified candidates should APPLY NOW for immediate consideration! - Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. -
  
  Thank you! -
  Lailun Sheikh -
  Phone: 412-763-1477 -
  Lailun.Sheikh@innovasolutions.com -
  
  PAY RANGE AND BENEFITS: -
  Pay Range*: $60.00-$78.00 per hour. -
  *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. -
  
  Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). -
  
  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. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. -
  
  Recent Recognitions: -
  
  
  • Named One of America's Best Employers for New Grads by Forbes (2024 -
    • Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025) -
      • One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024) -
        • One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics) -
          • Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023) -
            • One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024) -
              • AWS Advanced Tier Services Partner with 100+ certifications -
                Website: https://www.innovasolutions.com/ -
                
                Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.--- If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed.--- Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.------ Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. - 1324b. -
                The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. -
                
                Benefits: -Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
                
                
                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. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
                
                
                -Recent Recognitions:
                
                • One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
                • ClearlyRated - Client Diamond Award Winner (2020)
                • One of the Largest Certified MBE Companies in the NMSDC Network (2022)
                • Advanced Tier Services partner with AWS and Gold with MS
                  Innova Solutions -is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. - If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please call (770) 493-5588. Please indicate the specifics of the assistance needed. - Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. - - Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. - 1324b.
                  
                  
                  The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
                  
                  

Keywords: Innova, Thousand Oaks , Mgr GRAAS Operations, Other , Thousand Oaks, California