About
Strategic Regulatory Medical Writing/Medical Affairs (Pharma & Device - 25 years)
- Leading/directing overall strategic regulatory medical writing function for the company (pharmaceutical, medical device, biotechnology) in multiple therapeutic areas (hematology/oncology, reproductive medicine, bone health, orthopedics, dermatology, cardiovascular, neurovascular, urology, infectious disease, rare disease, cancer Immunotherapeutics, vaccines, radiopharmaceutical therapeutics, and pharmacogenetics)
- Gap Analysis & Remediation Report in compliance with MEDDEV 2.7/1 Rev. 4 / MDR 2017/745 Liaising with payers, employer medical directors, medical policy personnel, and HCPs
- Locating, hiring, and managing internal/external consultants
- Monitoring company-wide clinical quality, assuring accurate information communication (medical communication) and full compliance with legal/regulatory guidelines
- Regulatory filings (FDA, EMA, MHRA, Health Canada, PMDA, NMPA, TGA, ANVISA, SFDA), compliance regulations for clinical trials, new drug/device development (GLP, GMP, ICH-GCP certificates), data privacy laws, patient safety, adverse event reporting, site compliance, pharmacovigilance/drug safety
- Regulatory writing, including SOP, Protocol, Protocol Amendment, case report, pipeline drug compendia/dossier, company core data sheet (CCSI), eCTD modules 2 (including Summary of Biopharmaceutic Studies, Summary of Clinical Pharmacology Studies, summary of Clinical efficacy [SCE], Summary of Clinical Safety [SCS]) and 5 (Clinical Study Report [CSR])
- Supporting the medical component of pharmacovigilance/drug safety activities (surveillance, providing scientific/clinical PV expertise, along with identification, evaluation, and management of safety risks)
- Preparing/reviewing aggregate (integrated summary of safety [ISS], development safety update report [DSUR], periodic safety update report [PSUR], periodic benefit-risk evaluation report [PBRER], periodic adverse drug experience report [PADER]) and individual (SCS) safety reports, and risk management plan (RMP)
- AI Expertise: Experience with LLM orchestration platforms (Microsoft Copilot on Azure), OpenAI models (GPT-4/5 family, ChatGPT), and Google DeepMind Gemini models
- Instructional design via Criterion-Referenced Instruction (CRI), Continuing Medical Education (CME), Curriculum, live / on demand webinar, and e-learning development
- Managing CRM system, communication with physicians and health care professionals about investigational/approved products
- Literature surveillance, competitive intelligence, KOL intelligence, and preparation of medical information letters
- Supporting sales/marketing with new client acquisition/management, provider communication, and social media strategies
- Medical marketing document development/compliance review (abstract, manuscript, proposal, product knowledge material, poster, websites, blog, e-learning modules, social media marketing strategy)
- Global publication planning leadership (based on GPP) in multidisciplinary teams
- Market research, market intelligence, regulatory intelligence (Cortellis), survey development/management (Qualtrics)
- Member of the American Medical Writers Association (AMWA), Regulatory Affairs Professionals Society (RAPS), American Society for Quality (ASQ), and Project Management Institute (PMI)
