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WHAT
IN
Manager Submissions Management
Job
Takeda Pharmaceuticals
US
-
Deerfield,
Illinois
Job Code - 0900684
Position - See job description
Job First Active on: Sunday, November 01, 2009
APPLY TO THIS JOB (You will be applying directly to Takeda Pharmaceuticals for this position!)
JOB DESCRIPTION: Manager, Submissions Management
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 - QUALIFICATIONS: Manager, Submissions Management
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.
Takeda Pharmaceuticals
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