Title: Manager(Submission Manager )
Location: Lawrenceville, NJ
Job ID: 21390-1
Duration: 3+ months with potential for extension
DESCRIPTION:
Submission Manager
Division: Research and Development
Function: Global Regulatory Sciences and Biometrics
Expected Areas of Competence
1. Executes and oversees the preparation and submission of Client global regulatory dossiers.
2. Utilizes regulatory experience to determine submission content and execution strategy.
3. Demonstrates strong working knowledge of global regulatory practices, electronic submission guidelines and requirements by planning, managing and overseeing the operational aspects of the production of high quality submissions across various therapeutic areas and of various submission types (IND, BLA, NDA, Safety, etc.) .
4. Leads and/or actively participates in project sub teams to ensure the execution of submissions.
5. Responsible for producing the table of contents for submissions and ensuring the completion of the submission by overseeing delegated activities.
6. Contributes to Client policies and procedures required to ensure the validated and successful execution of submissions.
7. Manages and/or coaches the resources involved in building submissions for publishing.
8. Coaches peers and others to improve staff knowledge and expertise.
9. Proactively identifies areas of improvement and innovation across expertise area(s) and drives the department toward improvement.
10. Ability to communicate work activities and priorities to others to ensure completion of on-time deliverables.
11. Tracks progress of documentation and all components for dossiers. Interacts with responsible parties to aid in ensuring that components are received in a timely manner.
12. Operates as the functional area expert in terms of dossier production, provides direction, fosters effective team skills, and drives production of results based upon experience.
13. Establishes and executes plans and influences others in managing workload within their assigned project(s) through efficient resource utilization and within designated timeframes. Effectively adjusts plans to deal with changes and obstacles.
14. Participate in the development or review of health authority policy (REACT Teams).
15. Thinks and acts in a clear, decisive manner, remaining calm under adverse conditions. Influences others to do so. Reaches independent, reasoned solutions on complex issues.
16. Ensures dossiers and documentation meet electronic regulatory submission requirements, as applicable.
17. Reviews dossiers and also assists others in reviewing dossiers as needed.
18. Provides Global Dossier Management input regarding regulatory submissions strategy based on regulations/guidances and prior experience.
19. Strongly supports Dossier Lead and other regulatory functions as appropriate.
20. Anticipates and interprets key trends and changes in the submission environment and provides strategic guidance on submission plans as a result.
21. Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, Communicator, Access, Documentum, eCTD viewers and web based applications) and be technically savvy with such systems.
Knowledge Desired:
• Excellent command of English language, both written and oral.
• Knowledge of US and/or European regulatory processes and organization, state-of-the-art knowledge of US, European and ICH regulatory submission requirements, basic knowledge of other international regulatory requirements.
• An in-depth knowledge of Client policies and procedures related to the drug development and regulatory processes.
• In-depth knowledge of electronic submission requirements.
• Knowledge of dossier publishing tools and submission validation procedures.
• A B.S. in a relevant field with 7 plus years of pharmaceutical industry experience, or an M.S. in a relevant field with 5 years of pharmaceutical industry experience, or a Ph. D. in a relevant field with 4 years of pharmaceutical industry experience, or equivalent.
• A minimum of 2 years in regulatory affairs/operations is required.
• A minimum of a Bachelor degree in a relevant scientific or analytical field.
• Pharmaceutical experience and a basic knowledge of drug development desired. Level will commensurate with experience.
• Understanding of submission principles and decision-making processes of health authorities is a plus. Level will be commensurate with experience.
• Be able to, at times, work long hours; sometimes including nights, holidays and weekends.
All your information will be kept confidential according to EEO guidelines.