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Click here or scroll down to respond to this candidateCandidate's Name , MSPhiladelphia, PA Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLEhttps://LINKEDIN LINK AVAILABLESUMMARYRegulatory:Principal Medical Writer: Global Medical Writing Manager Lead with over 30+ years of pharmaceutical and medical knowledge. Experience with ICH, FDA, and EMA guidelines.Therapeutic areas of expertise include oncology (eg, tumors, radionuclide oncology treatments), respiratory/allergic rhinitis, asthma, rare diseases, type 2 diabetes/dyslipidemia, neurology/CNS, analgesia, cardiovascular, endocrinology, monoclonal antibodies, womens studies, IBS, UC, and dermatology.Author, QC reviewer, and supervisor of Phases 1 to 4 documents: CSRs, IMPDs, regulatory responses, safety narratives, protocols, IBs, Fit-For-Purpose Responses, briefing packages, summary documents/modules, IND updates (for US and EMA submissions).Participated in the development and management of clinical pharmacology studies spanning Phases 1 to 4.Developed and reviewed CRFs/eCRFs for protocol development and post-study evaluation.Supervised many Public Disclosure Synopses for a global pharmaceutical client that encompassed Phases 1 to 4 and OTC studies, in multiple therapeutic areas.Experienced CRA.Management:Managed a $2.6 million project and 5-10 Medical Writers: responsible for content consistency for a global pharmaceutical clients multi-study, Phase 3 NDA initiative for a type 2 diabetes, monoclonal antibody, PCSK9 inhibitor. Lead content supervisor and responsible for the management of junior medical writers.Experience managing international Medical Writers of various levels.Supervising cross-functional global project teams to progress documents forward in development.Communications:Published author and QC reviewer for manuscripts, abstracts, posters, and slide kits.Projects include developing educational slide kits for CME/CNE credits, annotations for primary review articles, and formulating questions for Pharmaceutical Representative training.Developed CME initiatives (e.g., slide kits and monographs) with key opinion leaders, pharmaceutical companies, and prominent universities.Managed a $7.0 CME initiative with key opinion leaders in cardiology that focused on the writing and development of a comprehensive core curriculum resource kit for the Heart Protection Study/type 2 diabetes (with over 250 slides with detailed speaker notes) for CME credits with emphasis in the areas of cardiology, endocrinology, dyslipidemia, and primary care with an AAFP-approved monograph on CV risk, with emphasis on dyslipidemia in special at-risk populations.Primary duties as lead or contributing writer for publication plans. Wrote abstracts, posters, and manuscripts from source documents/data for drugs in Phases 3 and 4, and OTC products.General:Proficient in electronic template use and review programs, eg, Veeva Vault, StartingPoint, SharePoint, and PleaseReview.Clinical:Prior to working in drug development, worked for over 7 years as a Medical Case Manager, supervising treatment teams and presenting to neurosurgeons and other professionals regarding the treatment of patients with traumatic brain injury.PHARMACEUTICAL INDUSTRY EXPERIENCEWrite On The Beach, LLC, Philadelphia, PAPresident/Company Owner, Principal Medical Writer/Global Medical Lead Dec 2004 Present [Primarily Remote, some onsite visits as requested]Senior level regulatory writing projects including Investigator Initiated Trials (IIT) Phase 2 protocol design and development, Section 14.3.3.1 SAE Narratives, lead author for Phase 2 CSR, Phase 3 CSR shells, Section 2.7.1 QC, Section 2.7.4 author, Phase 3 protocols, Phase 3 protocol amendments, Module 5 QC reviews, Phase 2 and 3 protocol QC reviews, IBs, summary documents, and FDA Briefing Books.Medical communications projects include developing educational slide kits, writing annotations for primary review articles, and formulating questions for educational games used for Pharmaceutical Representative training.Clients include:Argenx, Medical WriteroRegulatory documents (CSRs, IBs, Protocols) for orphan drugs.Endocyte/Advanced Accelerator Applications (the radioligand business of Novartis), Principal Medical WriteroOncology therapeutic area, radioligand therapy with specialty in prostate cancer.Senior level regulatory writing projects including Phase 2 Investigator Initiated Trials CSRs, Section 14.3.3.1 SAE narratives for oncology CSRs, protocol design and development, Phase 2 CSR shells, Phase 2 SAP shells, QC reviews, coauthoring of IBs and summary documents.Insmed Pharmaceuticals, Senior Medical WriteroWrote multinational Phase 2 protocol and Module 2.7.4 for rare diseases.Cerami Worldwide Communications, Principal Medical Writer/oEducational slide kits for pharmaceutical representatives and medical doctors for IB and UC.Wyeth Publications and External Communications Group, Sr Medical WriteroPrimary duties as lead or contributing writer for publication plans. Primary author for abstracts, posters, and manuscripts from source documents/data for drugs in Phases 3 and 4, and OTC products.oServed as lead QC reviewer for regulatory submission documents and training slide kits for global pharmaceutical client.EDUCATION/PROFESSIONAL AFFILIATIONSUniversity of Scranton, MS Health AdministrationUniversity of the Sciences in Philadelphia Graduate courses in Biomedical WritingEast Stroudsburg University, BS Biology concentration Laboratory MedicineMember of the American Medical Writers Association since 1995 |
