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Regulatory Document Associate
Ref No.: 18-00495
Location: Lawrenceville, New Jersey
Position Type:Contract
Start Date: 04/13/2018
REGULATORY DOCUMENT ASSOCIATE
LAWRENCEVILLE, NJ
Document Associate, Global Dossier Management
Function: Global Regulatory Sciences

Project Description:
  • Possesses an in-depth expertise in desktop applications utilized in electronic management.
  • Establishes partnerships with peers, management and client community to develop and maintain trust and an open flow of communication.
  • Fosters a team-based collaborative environment promoting candor, a high commitment to excellence to receptiveness to change.
  • Coaches and motivates subordinates to have a high degree of personal accountability and demonstrate teamwork.
  • Leverages collective knowledge to increase performance, productivity and responsiveness through innovation.
  • Effectively allocates resources to ensure the on-time delivery of documents to the client community.
  • Successful experience with electronic document management as part of a regulatory submission.
  • Demonstrated ability to effectively communicate with a diverse, multi-level audience using various formats.
  • Demonstrated ability to analyze, design and implements process improvements to maximize efficiencies.
  • Successful active participation as a change agent with a peer group.
  • Experience managing projects from conception to completion as part of a team.
  • Knowledge of electronic document management including a working knowledge of electronic regulatory submission guidelines and requirements.
  • Knowledge of effective supervisory techniques, which include coaching and motivating skills to lead a diverse team of word processing experts.
  • Solid understanding of change management concepts.
  • Awareness of clinical research from a broad business perspective as well as the ability to understand the impact of future change.
  • Mastery of metrics analyzing, reporting, and forecasting.
  • Gain understanding of business planning including the ability to set/prioritize goals and activities, allocate resources and anticipate potential issues.
  • Opportunity to enhance management/leadership skills.
  • Opportunity to expand technical expertise to support the rapidly changing applications environment.
  • Some exposure to senior management.
  • Develop a broader understanding of the organization.
  • Leadership Behaviors:
    • Talent Developer
    • Authentic Leadership
    • Change Agility
    • Enterprise Mindset


Required Skills:
  • Minimum – High School degree with 10 years industry experience or Associates degree in technical subject with 8 years industry experienced.
Preferred – Bachelor's degree in technical subject with 5 years of industry experience. At least 2 years supervisory experience required.
  • Has a mastery of desktop applications and regulatory submission procedures to effectively meet customer needs.
  • Mastery of electronic document management including a working knowledge of electronic regulatory submission guidelines and requirements.
  • Ability to train other in all publishing procedures for compliance with regulations.
  • Possesses the ability to troubleshoot and resolves complex desktop application issues. Responsible for implementation of procedural changes as appropriate. Informs staff of new information and leads procedure revisions for needed supplementary training.
  • In depth understanding of drug development and technical knowledge from a broad business perspective as well as the ability to understand the impact of future change. Makes recommendations for process improvements to comply with changes.
  • Mastery of metrics reporting and forecasting to set goals and objective and allocate adequate resources.
  • Understand of change management concepts.
  • Utilizes effective management techniques, which include coaching and motivating skills to lead/develop a diverse team of applications experts.
  • Developmental Value:
  • Opportunity to enhance leadership and management skills.
  • Opportunity to lead a large team.
  • Interface with senior management within and outside the department.
  • Thorough understanding of submission planning including the ability to adhere to establish timelines, to set/prioritize goals and activities, allocate resources and anticipate potential issues.
  • Develop a boarder understanding of the Client organization and the strategic business cycle.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jennifer: jennifer@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00495
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE