プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Michelle M.に依頼

United States

Board Member | Consultant | Advisor | Interim Leadership ✰ Regulatory Affairs ✰ Compliance & Ethics ✰ Quality Assurance

プロフィール概要

✰ Open to Work ✰ Available for Short & Long Term Engagements ✰ ✰ Available for due diligence, consulting, advisory, leadership and board opportunities through Pharmaceutical Compliance Partners, LLC. As an accomplished pharmaceutical leader, I have earned a reputation for crafting successful regulatory strategies and approvals, designing fit for purpose quality management systems, driving principles-based compliance initiatives and providing advice that empowers the business to better understand risk and make smart, informed decisions. I have a passion for leading teams, shepherding digital transformation and driving operational excellence. I’m passionate about drug development, especially for rare diseases and unmet medical needs. I enjoy advising small and mid-size companies on how to establish fit for purpose strategies, execute successful plans and define an operational infrastructure to guide assets from bench to clinical development to commercial launch and beyond. I can assist with: development plans, program management, regulatory strategy, submissions, FDA meetings, meeting requests, briefing books, orphan drug designation, expedited pathways, regulatory intelligence, advertising, promotion, labeling, due diligence, inspection preparation, RIM, regulatory processes, commercial compliance, ethics , compliance program frameworks, Consent Decree / Corporate Integrity Agreement (CIA) remediation, monitoring, risk management, review of medical information response letters, policy development, procedure development, code of conduct / code of ethics development, SOPs, process improvement, ethical interactions (HCP and patient), expanded access programs, quality assurance, quality systems, quality manual development, change control, product variation management, audits, quality agreement review, batch record review, CAPA, investigations, remediation, vendor oversight, deviations, jurisdictional control, training, PAI / PLI prep, mock inspections, etc. Through Pharmaceutical Compliance Partners, I’ve developed a network of great talent that can provide expertise across the life sciences domain. For more info, see PharmaceuticalCompliancePartners.com

専門分野

• ★ Regulatory Affairs
• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Regulatory Writing
• ☆ Product Compliance
• ☆ Medical Writing
• ☆ Management Consulting

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Market Research

Consulting Scientific and Technical Consulting

職務経験

Principal

Pharmaceutical Compliance Partners

3月 2018 - 現在

学歴

Doctoral Program

University of Southern California

8月 2014 - 現在

認定資格

• 認定資格の詳細は未入力です。