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Manager, Submission Planning and Analysis
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Manager, Submission Planning and Analysis : GlaxoSmithKline
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| Job Number |
53885 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Upper Merion
Pennsylvania
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| Salary (year) |
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| Experience |
6 to 9 Years |
| Start Date |
5/11/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Required Degree |
Bachelors Degree |
| Relocation |
Not Required |
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| Description |
Basic Qualification
Requires post secondary education plus 6-8 years pharmaceutical and project management experience, including experience in a matrix team environment. Required project management experience in a vaccines regulatory environment. Demonstrated proficiency in managing personnel and complex projects within a matrix team environment, effectively coordinating several projects/activities at different stages of development
Details
Partners with Regulatory Therapeutic Representative in leading multidisciplinary teams in the development of biological licensing applications. May represent Regulatory TA Representative on Project Teams in absence of Regulatory TA Representative Leads the creation and maintenance of submission plans. Ensures deliverables are in accordance with agreed timelines. Provides guidance on submission requirements. Leads the development of submission analysis processes and submission team best practices. Assures compliance of all GSK regulatory submissions with all applicable laws, regulations, and other requirements of FDA and other applicable agencies. Assures that all GSK US regulatory submissions meet ethical and scientific standards. Actively collaborates with Submission Team members and GSK staff who contribute to the submission process, proactively influencing the achievement of team objectives. Proposes and executes multiple submission plans and priorities; assigns and directs self and supporting/ matrix staff to achieve goals |
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| Requirements |
Preferred Qualification
Expert knowledge of regulations and ability to effectively evaluate impact of those regulations within the drug development environment. Demonstrated ability to independently lead a submission team. Routine collaboration with USRA Vaccine TA reps & matrix project teams to provide strategic technical regulatory input and US eCTD perspective addressing all topics for a variety of projects that span the development life-cycle (IND through post-marketing). An applied understanding of federal regulations and guidance’s applicable to investigational new drug (IND) application and biological license application (BLA) processes, as well as FDA electronic submission requirements, including but not limited to eINDs, eBLAs and eCTD. Demonstrated ability to lead and influence change in a matrix team environment. Proficient in the use of project management software, including the development and maintenance of project plans. |
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