Services AllDesktop publishing Editing of tables and graphs Graphic design Indexing Journalistic writing Medical writing Production editing Project management Proofreading Stylistic and copy editing Substantive editing Translation Web page design and/or programming Products/Media AllAbstract Advisory Board Meeting Summary Book Chapter Clinical Efficacy/Safety Summary Clinical Study Protocol Clinical Study Report CME Detail/Visual Aid Disease Overview Summary Drug/Disease Information Brochure Drug/Disease Monograph Grant Proposal Grant Proposals Integrated Efficacy/Safety Summary Investigator’s Brochure Journal Advertisement Lay Journal Article Market Access/Drug Formulary Documents Marketing/Sale Materials Newsletter Patient Education Materials Poster Press Release Proceedings Product Monograph Publications Regulatory Documents Research Paper Sales Training Manual Scientific Congress/Symposium-related Material Slide Kit Website White Paper Keywords A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z    ALL K Crystal Kaczkowski Region: Montreal Hello, I am a medical writer with over 10 years experience offering writing and editorial support to the pharmaceutical industry and medical communication agencies. With a Masters degree in the biomedical sciences, I possess a broad understanding of scientific concepts and the ability to research (conduct literature reviews) to write for a physician or laymen audience. I am experienced in several different areas of medical writing having worked in-house at Merck Frosst in Montreal (marketing copywriter) and in the United States at Pharmacia/Pfizer (regulatory/clinical writing) and Corbett Accel Healthcare group (marketing copywriter). I have written Phase 2-4 efficacy and safety regulatory documents (clinical study reports (CSR), investigator brochures (IB), clinical summaries for New Drug Applications (NDA), and Investigator New Drug (IND) annual updates, etc). Thus, I am able to grasp statistical concepts and coherently assemble them into a format customized for the client's needs. As well, I possess a considerable freelance portfolio including work such as: continuing medical education (CME) expert commentaries written for rheumatologists, medical encyclopedia articles (over 60 published), and an extensive competitive analyses produced for the Lipitor brand team (Powerpoint slide kits, Excel, Word). In addition, I have published research articles based on my own Masters research in peer-reviewed journals as a first-author. Although I am able to write about many different areas of medicine or science, the therapeutic areas I have substantial expertise in are rheumatoid arthritis, cardiovascular disease, and oncology. Some of the drugs/brands I have worked on include: Arthritis, inflammation and pain: Orencia (Bristol Myers Squibb) Acterma (Roche) Celebrex, Bextra, Dynastat, CDP-870 (Pfizer) Lyrica (Pfizer) Cardiovascular medicine (cholesterol, diabetes, high-blood pressure): -Lipitor (Pfizer) -Crestor (AstraZeneca) -Zetia/Ezetrol (Merck) -Vytorin (Merck) -Cozaar and Hyzaar (Merck) -Januvia (Merck) -Exubera (Pfizer) -Caduet (Pfizer) -Plavix (Bristol Myers Squibb, Sanofi-Aventis) Oncology: -Erbitux (colorectal & head and neck cancer) -Alimta (Eli Lilly, lung cancer) -Caelyx (Schering-Plough, ovarian cancer) -Rituximab (Genentech, chronic lymphocyctic leukemia/idiopathic thrombocytopenic purpura -Emend (Merck, chemotherapy-related nausea/vomiting) -Various articles written for the Thompson Gale Encyclopedia of Cancer Bipolar disorder/schizophrenia: -Abilify (Bristol Myers Squibb) -Risperdal (Janssen-Ortho) Migraine: -Maxalt (Merck) Nutrition: -Various articles/scientific papers published Allergy: -Singulair (Merck) Vaccines: -Rotateq (Merck) Eye Disorders: -Systane, Infiniti, and Ladarvision (Alcon) Furthermore, I have written many other articles regarding basic medicine and devices (ie. sales materials for Ladarvision, an excimer laser for eye surgery). Available at short notice to travel worldwide to scientific conferences, advisory board meetings, etc. I provide quick turnaround with error-free copy. Work samples available upon request (in the therapeutic area that interests you) or simply visit my website or Google in my name for more information that you would ever want to read. Lastly, I have contacts with a dependable team of professionals which includes a physician, a translator, a graphic designer, as well as other copywriters to offer you research, copy, layout, and final, printed document(s) should you require it. Big or small jobs welcome. Please email me as as initial contact and I will return your call promptly. Services Editing of tables and graphs Graphic design Journalistic writing Medical writing Project management Proofreading Stylistic and copy editing Translation Web page design and/or programming Products/Media Research Paper Clinical Study Protocol Clinical Study Report Investigator’s Brochure Integrated Efficacy/Safety Summary Product Monograph Disease Overview Summary Clinical Efficacy/Safety Summary Newsletter Slide Kit Drug/Disease Monograph Detail/Visual Aid Journal Advertisement Press Release Advisory Board Meeting Summary Sales Training Manual Abstract Poster Proceedings Website Drug/Disease Information Brochure Lay Journal Article Publications Regulatory Documents CME Marketing/Sale Materials Scientific Congress/Symposium-related Material Patient Education Materials Address Please email me as as initial contact and I will return your call promptly. Pincourt (suburban Montreal), QC J7V 9V5 Phone 514-xxx-xxxx Email medicalwriter@videotron.ca Website http://www.medwrite.ca Ludmila Kovtiuh Region: Toronto Certified Sr. Research Scientist/Manager, PhD with more than 10 years of program/project management and medical/scientific writing experience gained from academia and pharmaceutical industry. More than 6 years provided scientific and operations management support in development, implementation, reporting and publishing of over 30 Phase I-IV global and local clinical trials for NA pharmaceutical industry, including for top 5 leading companies. Strong ability to analyse and interpret research data, to recognize efficacy and safety data trends transformed into writing of high quality submission-ready documentation. Applied skills in managing multiple tasks, activities and priorities with professionalism, urgency and integrity while meeting project deadlines. Proven ability to work effectively in a matrix team and build strong business realtionships. Excellent record of achievements with constant focus on meeting or exceeding project goals by delivering an industry-leading performance. Flexible, reliable and nice work ethic. TECHNICAL SUMMARY RELATED EDUCATION & TRAINING: PhD degree in Biology (Genetics), MS-BS degree in Biology & Chemistry (double major) and Nursing Diploma. Post-doctoral training in Pharmacology and Environmental Epidemiology. Formal Industry project management training. Working knowledge of clinical trial activities and ICH/GCP/TPD/FDA/EMEA guidelines. 42 scientific publications on award winning research conducted under my leadership and supervision. IT/EDMS: Advanced computer, bio-statistics and data analysis skills. MS Windows (2000/XP/VISTA); MS Project, MS Office Suite, e-Documentum, RISE, ELARA, STARS, InForm, eTrack, OnSite, Adobe; SAS, Statgrafics and Biostat. AREA OF EXPERTISE: Program/project management and medical writing. Applied experience in oncology, women’s health, immunology, vaccine research, rheumatology, cardiology, medical devices (coronary stents), neurology, infectious (hepatitis), gastrointestinal (GI) and respiratory diseases; public health, clinical and environmental epidemiology. ADDITIONAL LIST OF SERVICES REGULATORY/SCIENTIFIC/TECHNICAL WRITING * Phase I-IV Clinical Study Protocols * Protocol Concepts * Clinical Data Analysis and Interpretation * Statistical Table Preparation. * Interim/Final Clinical Study Report. * Investigational New Drug Submission (IND). * New Drug Submission (NDS). * Biological License Application (BLA). * ISS/ISE in e-CTD format. * Abbreviated New Drug Submission (ANDS). * Supplemental New Drug Submission (SNDS). * NDS/SNDS/BLA Correspondence. * Literature Review and Bibliography. * Expert Report and Proposal. * Study Operational Manual Development. * Contribution in CRF Development. * Informed Consent Writing. * Manuscript and Abstract. Services Editing of tables and graphs Medical writing Project management Proofreading Stylistic and copy editing Substantive editing Translation Products/Media Research Paper Grant Proposal Clinical Study Protocol Clinical Study Report Investigator’s Brochure Integrated Efficacy/Safety Summary Product Monograph Disease Overview Summary Clinical Efficacy/Safety Summary Slide Kit Drug/Disease Monograph Sales Training Manual Abstract Poster Proceedings Drug/Disease Information Brochure Publications Grant Proposals Regulatory Documents Market Access/Drug Formulary Documents CME Marketing/Sale Materials Scientific Congress/Symposium-related Material Patient Education Materials Address Manorhampton Toronto, ON M9P 1E2 Phone 416-240-1406 Email lpkw@rogers.com Flora Krasnoshtein Region: Toronto I am a medical writer with a B.Sc. in Biology and a M.Sc. in Molecular and Medical Genetics. My background is diverse, ranging from pharmaceutical and healthcare advertising, with a knowledge of PAAB, continuing medical education (CME) and web-based and print consumer-oriented healthcare information to academic writing and scientific research. My research experience ranged from experiments funded by the Canadian Space Agency, in collaboration with NASA, to study bone loss in space, to gene expression studies to rheumatology. I offer medical writing services for a wide range of healthcare communication and educational materials for both print and online publications for Canadian and U.S. clients. I have experience writing on a diversity of pharmaceutical brands spanning a wide range of therapeutic areas for both professional and consumer audiences. Other services include scientific/medical writing for peer-review publications, editing and rewriting, and comprehensive literature research for Medical, Pharmaceutical and Health Sectors. SUBJECTS: Selected therapeutic areas of experience (brands) that I have worked on include: (Please contact the writer for a complete list of therapeutic areas and pharmaceutical brands, and types of projects and media) · Allergy / Immunology Oral antihistamines (Reactine, Aerius) · Antibiotics (Biaxin XL and Pediatric; Cipro) - Detail aids, cards (dose, indication) · Blood disorders Hematology, hemophilia (Kogenate) · Anxiety/Depression (Effexor/Effexor XR) Specialist Reprint Carrier; Slim Jim Detail Aid; Journal Ad (Anxiety/Depression); Pegasys (Roche) - Depression and hepatitis C – healthcare professional folder and patient tear pad · Cancer / Oncology Chemotherapy-induced anemia (Procrit), breast cancer, head and neck cancer (Taxotere), breast cancer (Arimidex), epidermal growth factor receptor tyrosine kinase inhibitors (erlotinib and gefitinib) in non-small cell lung cancer NSCLC, pancreatic cancer, ovarian cancer (Gemzar), NSCLC (Tarceva); prostate cancer (Casodex, Zoladex); Hematological malignancies (non-Hodgkin’s lymphoma (NHL) (Rituxan); skin cancer prevention and treatment, caregiving, men’s health · Cardiovascular / Cardiology Heart disease, cardiovascular disease (Mavik); Drug-eluting stents (Cypher); Dyslipidemia CME (Crestor, rosuvastatin, and other statins); Hypertension (Atacand; Coversyl); Peripheral arterial disease, PAD and cerebrovascular disease (Plavix); Pulmonary arterial hypertension, PAH (Tracleer) · Dentistry Dental implants; oral health; Listerine · Diabetes Diabetes therapies and delivery systems (Medtronic Insulin Pump); International Diabetes Federation (IDF) Youth Diabetes Charter – slide presentation for ADA meeting 2007; Diabetes Therapy in Canada: Addressing barriers to drive towards optimal care - overview of different therapeutic options in diabetes · Endocrinology Hypothyrodism (Synthroid); Small gestational weight; growth hormone (Saizen) · Gastroenterology Crohn’s disease, ulcerative colitis, inflammatory bowel disease, IBD (Remicade); acid reflux (GERD) (Nexium, Prevacid); constipation (Senokot); inflammatory bowel disease (IBD) · Growth Disorders Growth hormone, growth deficiency (Saizen) · Herbal and Nutritional Supplements · HIV/AIDS (Invirase, Fuzeon); pregnancy and HIV · Immunization / Vaccination Childhood vaccinations (Pentacel, Quadracel), pneumococcal disease (Prevnar); Travellers’ Diarrhea (Dukoral) · Molecular and cellular biology HPV Diagnostic Kit (Amplicor) · Multiple sclerosis / Neurology MS (Copaxone, Avonex, Rebif) · Obesity Weight management, weight control (Meridia) · Osteoporosis Bone health, bone loss, bisphosphonates (Arimidex), (Premarin/Prempro) · Psychiatry / Neurology Schizophrenia, bipolar disorder (Seroquel); generalized anxiety disorder (GAD), depression, social anxiety disorder (SAD), mental health (Effexor); Attention Deficit Hyperactivity Disorder (ADHD); Attention Deficit Disorder (ADD) (Concerta) · Respiratory/ Pulmonary Chronic obstructive pulmonary disease (COPD), (Spiriva), asthma (Patient and pharmacist education on inhalers); Patient Awareness Program (Symbicort) · Rheumatology Rheumatoid arthritis, ankylosing spondylitis (Enbrel, Humira, Remicade) · Skin Disorders /Dermatology Plaque psoriasis (Raptiva); psoriatic arthritis (Amevive, Enbrel, Humira, Remicade); Eczema – management guide for pharmacists · Smoking Cessation / Nicotine Replacement Therapies (NRT) (Nicoderm, Nicorette Gum, Nicorette Inhaler) · Solid Organ Transplantation Creatinine clearance dosage adjustment (Valcyte), skin cancer after kidney transplant (Rapamune); CNI-free protocols, kidney transplantation (literature research and bibliography); Backgrounder on challenges to current treatment in kidney transplantation; Fact Sheet on donor criteria and the need for kidneys · Surgeries Analgesic, pain management; abdominal surgeries (appendectomy, colecystectomy, hysterectomy); orthopedic surgeries, hip replacement and knee replacement (Ionsys) · Urology Overactive bladder (OB) (ImmuCyst), (Detrol) · Virology / Infections Hepatitis C (Pegasys), cytomegalovirus infection (CMV), creatinine clearance (Valcyte), HIV (Invirase, Fuzeon) · Woman's health Gynecology, Birth control, oral contraceptive (Ortho Tri-Cyclen), menopause, osteoporosis, bone loss (Premarin/Prempro), breast cancer For more information, please visit www.medwrite-canada.com. Services Editing of tables and graphs Medical writing Project management Proofreading Substantive editing Products/Media Research Paper Product Monograph Disease Overview Summary Newsletter Slide Kit Drug/Disease Monograph Detail/Visual Aid Journal Advertisement Advisory Board Meeting Summary Sales Training Manual Abstract Poster Proceedings Website Drug/Disease Information Brochure Lay Journal Article Publications CME Marketing/Sale Materials Scientific Congress/Symposium-related Material Patient Education Materials Address 210-490 Wilson Avenue Toronto, ON M3H 1T8 Phone 416-398-1333 Email flora.krasnoshtein@sympatico.ca Website http://www.medwrite-canada.com Caroline Kwiatkowska Region: Montreal Caroline Kwiatkowska, a Canadian-trained MD with an MBA, is an experienced medical writer and editor who founded BizMD. She practiced as a family physician for 8 years in Ontario. This was followed by 6 years of pharmaceutical experience working in top 10 pharma companies. During her work in the pharmaceutical industry, she found there was a need for knowledgeable medical writers, who not only have solid writing skills but also a clear understanding of the medical and business challenges. To address this need, she founded BizMD in September 2006. Clients appreciate her clear and concise documents. She is proficient at translating complex clinical data into clear messages for both scientific and lay audiences. For more information: www.bizmd.ca Services Editing of tables and graphs Journalistic writing Medical writing Project management Stylistic and copy editing Substantive editing Products/Media Research Paper Book Chapter Clinical Study Protocol Clinical Study Report Investigator’s Brochure Integrated Efficacy/Safety Summary Product Monograph Disease Overview Summary Clinical Efficacy/Safety Summary Newsletter Slide Kit Drug/Disease Monograph Advisory Board Meeting Summary Sales Training Manual Abstract Proceedings Website Drug/Disease Information Brochure Lay Journal Article Publications Regulatory Documents Market Access/Drug Formulary Documents CME Scientific Congress/Symposium-related Material Patient Education Materials Address TBA Pierrefonds, QC TBA Phone 514-421-3725 Email caroline@bizmd.ca Website http://www.bizmd.ca

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