Tiffini G. Email & Phone Number

A am a self-motivated medical writer with over 20 years of experience in the quality, regulatory, pharmaceutical, and clinical research industries.Specialties: •Therapeutic areas: Oncology/Hematology, Rare Diseases, Immunology, Infectious Disease, Psychiatry, Gynecology, Endocrinology, Cardiology, Gastroenterology, Neurology, Pain Medicine, Virology, Orthopedics, Vaccines, Medical Devices, Dermatology, Respiratory, Urology, Ophthalmology, CNS•Medical/Technical documents: Clinical study reports (CSRs), informed consent forms (ICFs), clinical study protocols/amendments, investigator brochures (IBs), patient narratives, plain language summaries, patient diaries, clinical educational materials, 510(k) documentation, investigational new drug (IND)/investigational medicinal product dossier (IMPD) modules, biologics license application (BLA) modules, new drug application (NDA) modules, briefing documents, safety update reports, breakthrough designations, pediatric investigation plans, product labels, risk management plans, risk analyses, posters, manuscripts, monitoring visit reports, validation protocols/reports, material safety data sheets, document and process change controls, orphan drug submissions, proof of concepts, standard operating procedures (SOPs), process summaries, root cause analysis plans, operating principals, functional and user requirements. •QA/RA, Compliance, Audits & Inspections, Complaints, Field Alerts-Recalls, training, etc.•Experienced with US Food and Drug Administration (FDA), Health Canada, European Union, European Medicines Agency (EMA), Medicines & Healthcare products Regulatory Agency (MHRA), Chinese National Medical Products Association (NMPA), Australian Drug Evaluation Committee (ADEC), and Ministry of Health, Labour and Welfare regulations and submissions.