Joe K.

I’m a seasoned medical writer, editor, researcher, and naturopathic medical doctor. I specialize in content and technical writing for health and wellness. With hands-on experience in clinical trials, my expertise extends to regulatory submissions of natural health products, cosmetics, and medical devices. My clinical experience in integrative patient care, combined with a background in conventional and naturopathic medicine, complements my writing. As a medical writer, I have expertise both in technical and content writing (see specialized profiles). As a proofreader/editor/peer-reviewer, I have exceptional ability in proofreading and revising texts, checking spelling, grammar, typos and explaining required changes to the authors. I am proficient in copy editing, clarification, line by line editing, developmental editing, structural editing and stylistic editing. As a researcher, I am highly competent in online literature research which involves defining the question, framing an answerable, searchable question, analyzing the question, identifying appropriate resources to answer the question with the construction of the search strategy, evaluating the search process and the information and applying information to the question. I am adept in data collection, data entry, data verification, content review, content management, qualitative and quantitative analysis. In addition, I have developed expertise in the field of medical devices related to regulatory compliance, clinical consulting and support on quality assurance. Regulatory compliance includes preparation of medical device license and establishment license applications, regulatory submissions, guidance on medical devices classification, importing and distribution, and risk management of medical devices. Clinical support includes writing and proofreading clinical background section of the license applications to FDA and Health Canada, database search for Adverse Events and literature search for clinical trials of medical devices. Support on Quality Assurance includes establishing a quality management system (QMS) for medical devices, documenting and planning a QMS for medical devices, resource and product realization management, root cause analysis and tracking deviation. I also provide consultation related to Natural Health Products which includes regulatory compliance and support on quality assurance. Regulatory compliance includes managing submission of regulatory applications to Health Canada for NHPDs, performing database search for the ingredients ensuring the presence of NHPDs in database, conducting a search for safety and efficacy of NHPDs from product monographs and literature, guidance on importing products, site license applications. Support on Quality Assurance includes ensuring the quality of the NHPDs from Certificate of Analysis and packaging labels. My interest in the writing world stems from my involvement as a post-graduate resident and clinical research coordinator in Medical Physiology in India while doing college work in Psychology and Social Sciences in the United States and during training as a Clinical Research Associate at McMaster University, Hamilton, Canada. Further, I have worked as a general practitioner in India and as a physician assistant in the US and Canada in primary care, and I have the superb capability of applying my medical knowledge for effective writing in this field. Additionally, I completed a naturopathic medicine doctor program in Canada with a naturopathic general medicine residency in the US. I cherish the blend of naturopathic and conventional medicine and have gained insight into the world of applied research and writing in the field of alternative medicine. Certifications: Certified in ISO 9001, 14971, 13485 Clinical Research specific skills: ICH GCP (E2, E3, E6, E8, E9, E10, E11, Q7, Q8, Q9), GMP, GVP, GCDMP,21 CFR 11, 21, 50, 54, 56, 210, 211, 312, 314, 812, 803, 820, 45 CFR 46, TCPS 2, Health Canada regulation Part C (Divisions 2, 5), Medical device regulations, Natural Health Product regulations Computer skills: Microsoft Office (Word, Excel, PowerPoint, Outlook); PubMed, Medline, FDA, Health Canada databases; MedDRA; Citrix, Same page workspaces; Biznet Clinical Trail Management system; database preparation; SPSS, SAS; Quality Management Systems; Clineo, Accuro, MedAccess, Athena Electronic Medical Records Medical skills: screening subjects, phlebotomy, doing ECGs and Spirometry Please contact me to discuss your project in detail and determine how my skills will positively contribute to your team.