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Project Lead Resume

PROFILE:

  • Accomplished pharmaceutical program/project leader with extensive experience in operations and management of development initiatives for diverse research programs.
  • Focus on organizations’ success by capitalizing on the written word to effectively convey successes, corrective actions, and ICH compliance toward research presented in regulatory submissions.
  • Goal oriented to achieve viable, efficient, and effective results for the development of promising therapeutics.
  • Flexible professional contributor and team leader.
  • Strategic Competencies designing organization and program development strategies and influencing adoption of recommendations to executive management and other stakeholders interpreting organization and program needs and distilling operational issues to support effective collaboration and negotiation with all contributors, including executive management and other influential stakeholders leadership and direction to multi - discipline teams, with an emphasis on creating a collaborative environment among operations teams, including independent contractors, consultants, and vendors (i.e., “virtual” teams) creating and implementing effective communications and relationship bridging plans for virtual teams translating data, regulations, and organization policy into practice toward program work and goals negotiating agreement among stakeholders and building consensus
  • Operations Competencies designing written documentation to support and lead regulatory submissions with an emphasis on early stage planning, including crafting effective INDs and regulatory-oriented White Paper submissions performing Medical and Technical Writing projects; including Protocols, Investigator Brochures, Clinical Study Reports, Annual IND Safety Reports (DSURs), IND and NDA Modules, SOPs, Regulatory Meeting Requests, One Page Project Communications, Study Manuals, Project/Program Operations Manuals, as well as providing
  • Review services to other Writers for these types of documents advisory capability toward the creation of operational infrastructure, including specialized electronic and paper filing systems to meet the Quality and SOP requirements of small organizations detailed knowledge of the preparation of R&D level summaries filling overtly operations-oriented roles in Quality, clinical development, project/program management, as well as R&D level cross-project planning, program management, and documentation on cross-functional teams providing leadership and review oversight to external contributing experts in functional areas including Non clinical, CMC (API and dosage forms, plus documentation), Safety Surveillance, Clinical, and Regulatory preparing and delivering presentations to audiences to support understanding of and enthusiasm for program goals and plans creating and documenting processes and procedures surrounding both strategic and operations goals skilled in multiple software paradigms including Microsoft Office Suite of infrastructure and operations software; including Office 365, Word, Excel, SharePoint, Project, and PowerPoint, as well as Adobe, TrackWise and recipient level exposure to SalesForce output

PROFESSIONAL EXPERIENCE:

Confidential

Project Lead

Responsibilities:

  • Bi-directional consulting to both Operations and Executive Management; responsibilities to CMO, CFO, and VP Clinical Research, as well as cross functional Team Lead
  • Communication planning with 3rd party providers to create regulatory document development strategy, providing direction to contributors to develop key messages and strategic direction
  • Prepared and designed poster publication to be presented by the CSO/CEO at international conference
  • Managed and reviewed vendor deliverables, including Safety Surveillance, API and dosage form CMC services, and TMF management

Confidential, Cary, NC

QA lead

Responsibilities:

  • Gap analysis of proprietary questionnaire tools to create vendor specific evaluation tools and process.
  • Directed and managed the questionnaire completion and dynamic interview process
  • Crafted recommendations for vendor qualification deficiencies and provide recommendations to client

Confidential

Quality Assurance consultant

Responsibilities:

  • Research and assessment of outstanding Corrective and Preventive Action (CAPA) initiatives
  • Executed a newly-mandated, cross-functional documentation process for Quality Assurance-oriented documentation for clinical development projects
  • Advisory member to multiple operations project teams

Confidential

Quality Assurance consultant

Responsibilities:

  • Leadership and advisory member to Pre-approval Inspection (PAI) Readiness Team for a key program slated to be scrutinized by Confidential with both Sponsor/Monitor and multiple clinical site inspections
  • Advisory member to multiple operations project teams
  • Gap analysis for PAI Readiness and management of Team to achieve Readiness prior to Confidential Inspections
  • Management of "War Room" Questions/Responses exercise for PAI
  • Preparation and team management of review of Responses to Confidential PAI Findings

Confidential, Research Triangle Park, NC.

Regulatory Affairs consultant

Responsibilities:

  • Advice toward Regulatory strategies available for life saving therapies for unmet medical needs
  • Gap analysis for regulatory infrastructure in general
  • Regulatory Affairs support for IND Serial Amendments
  • Creation of Regulatory SOPs

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