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Regulatory Sub Specialist
| Details |
Country: USA
Location: Collegeville PA
Total applied: 40
Location: US-PA-Collegeville Company:Wyeth Job Description:
As the Regulatory Submissions Specialist, your primary responsibilities will be to coordinate and publish high quality submissions according to plan following Wyeth and Health Authority guidance and procedures. This includes understanding the complexity of submissions and ensuring that submissions are complete with all issues/gaps rectified prior to management review. You will also be responsible for the final dispatch and archive of the submissions. You will enter submission information in Viewpoint, execute all associated tasks through the Viewpoint application, and ensure all databases and reports reflect the information in Viewpoint. You will identify technical and basic content problems, demonstrate problem-solving abilities by providing possible solutions and follow issues to resolution. You will participate in procedure development by providing process improvements (efficiency, quality, cost, etc.) for simple and complex processes and draft procedures and follow procedures through to approval. Additional administrative and technical duties will be performed as assigned.
This position requires a Bachelor's degree in a scientific/technical major and 4 years experience or a Master's degree and 2 years experience. Knowledge of Agency regulations and guidelines relating to submission types for major (NDA, BLA, MAA, etc.) and minor (amendments, supplements, etc.) submissions. Training on multiple computer programs/systems and two-plus years of experience with computers and computer software is required. Previous experience with publishing and Agency requirements. Ability to multitask and remain calm and focused under tight deadlines and pressure is necessary.
Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.
For more information, visit our website at http://www.wyeth.com
Wyeth is an Equal Opportunity Employer, M/F/D/V.
Search Firm Representatives:
Please Read Carefully.
Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into prior with Wyeth to January 2004 is hereinafter void.
Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals. Requirements: Please see Job Description
Apply By Email:
Ref ID: 46538866
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For 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 >> |
|
Regulatory Sub Specialist
As the Regulatory Submissions Specialist, your primary responsibilities will be to coordinate and publish high quality submissions according to plan following Wyeth and Health Authority guidance and procedures. This includes understanding the complexity of submissions and ensuring that submissions are complete with all issues/gaps rectified prior to management review. You will also be responsible for the final dispatch and archive of the submissions. You will enter submission information in Viewpoint, execute all associated tasks through the Viewpoint application, and ensure all databases and reports reflect the information in Viewpoint. You will identify technical and basic content problems, demonstrate problem-solving abilities by providing possible solutions and follow issues to resolution. You will participate in procedure development by providing process improvements (efficiency, quality, cost, etc.) for simple and complex processes and draft procedures and follow procedures through to approval. Additional administrative and technical duties will be performed as assigned.This position requires a Bachelor's degree in a scientific/technical major and 4 years experience or a Master's degree and 2 years experience. Knowledge of Agency regulations and guidelines relating to submission types for major (NDA, BLA, MAA, etc.) and minor (amendments, supplements, etc.) submissions. Training on multiple computer programs/systems and two-plus years of experience with computers and computer software is required. Previous experience with publishing and Agency requirements. Ability to multitask and remain calm and focused under tight deadlines and pressure is necessary.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at
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