Skip Header Section
 Back to Search Results >>

Manager, Submissions Management

Apply Now >> Save it
 |  Email It
 |  Print it   |   		Report It
Job Snapshot
Location:
Chicago, IL 60601 (map it!Map it! )
Employee Type:
Full-Time
Industry:
Pharmaceutical
Manages Others:
Not Specified
Job Type:
Health Care
Experience:
Not Specified
Travel:
None
Post Date:
10/30/2009
Contact Information
Ref ID:
0900684
Description OBJECTIVE
 
  • Furnish expert technical and subject matter expertise in the requirements for electronic and paper submissions.
  • A broad understanding of business processes, practices, and requirements, including applicable regulatory requirements for electronic and paper submissions.
  • In-depth knowledge of the numerous technologies utilized for the creation and management of submission and submission supporting documents.
  • Communicate requirements for electronic submission development throughout the organization.
  • Lead the development and deployment of training associated with submission publishing and related systems.
 
 
ACCOUNTABILITIES: 
  • Manages and leads staff to ensure timely, compliant submissions are filed with regulatory agencies.
  • Appropriately escalates internal issues for resolution of compliance-related problems encountered during planning or production phases of publishing electronic and paper submissions.
  • Collaborates with IT support groups to ensure necessary support is achieved and sustained to achieve high quality submissions.
  • Ensures publishing system is in compliance with internal and external requirements for electronic and paper submissions.
  • Works with drug development teams to ensure compliance with standards and regulatory guidances for documents used in submissions.
  • Evaluates staff and performs appropriate personnel management activities which include recommendations for hiring.
 
 
Requirements EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
  • BS degree; MBA or other advanced degree desirable
  • 5 years of increasing responsibility in the pharmaceutical or related industry
  • Knowledge of all drug development phases and requirements for submissions including research, development, manufacturing, quality assurance, compliance, and registration

 

TRAVEL REQUIREMENTS: 
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 10% travel.
 
 
Submit your resume and start a quality career with Takeda!
 
We are an equal opportunity employer.
www.tpna.com
 
No Phone Calls or Recruiters Please.

Apply Now >> Save it
 |  Email It
 |  Print it   |   		Report It
CareerBuilder.com AdviceFor your privacy and protection, when applying to a job online:
Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn More >>

By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
SPONSORED BY
   
Degree Driven

Thank you for your interest…

Thank you for your interest in the Manager, Submissions Management position.

To begin the application process, please enter your email address.

Email is invalid Email is needed

By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website.

 
Help  |   Job Seeker Customer Service: (866) 438-1485
CareerBuilder
Job Seeker Services

Fun Stuff
CareerBuilder International
Partner Sites

Employers