Project management: The key to MedComms success

Thomas is a knowledgeable medical writer with 20 years of experience providing regulatory and drug development advice to various pharmaceutical and food supplement companies across Europe, the US, and the Far East/Australia. He served as the Director of Regulatory and Clinical Affairs, regulating global negotiation and obtaining approvals for a leading therapeutics institution.

Key Experience:

• Over 20 years of global experience in providing regulatory and drug development guidance to pharmaceutical and food supplement companies.
• Broad understanding and management of worldwide regulatory negotiation and approvals.
• Previous high-ranking role as Director of Regulatory and Clinical Affairs in a leading therapeutics company.

Eileen is a seasoned pharmacist and medical writer with a strong 30-year history in the medical communication domain. Throughout her extensive career, she has demonstrated her expertise through contributions and reviews of clinical content including manuscripts, abstracts, and presentation materials, and has provided advisory and editorial support, competitor reviews, and database development. Possessing deep insight and knowledge in diverse therapeutic areas, her specialties range from ophthalmology and cardiovascular to diabetes, among others.

Key Experiences:

• A successful 30-year career as a pharmacist and medical writer.
• Spearheaded the development of various projects and publications, including manuscripts, abstracts, presentation materials, and database development.
• Acquired extensive therapeutic area expertise, notably in ophthalmology, cardiovascular diseases, and diabetes.

Hannah has an impressive career as a medical writer spanning over two decades. Her solid educational foundation in Biochemistry and Molecular Genetics, acquired from a top-tier university in the US, has greatly enriched her role in her current writing and editing team. For over 14 years, she has consistently delivered high-quality content in her speciality area of diabetes.
Hannah has crafted over 20 highly informative articles, all tailored to diabetologists/endocrinologists in Europe and Latin America. These outputs cover a myriad of topics in diabetes management and research, such as Diabetic retinopathy and hypertension in type 2 diabetes, the correlation between obesity, mental illness medication and type 2 diabetes, the role of neurotherapeutics in addressing obesity and its associated comorbidities, lipid management in diabetes, exploration on diabetic microvascular complications amongst many others.

Key highlights:

• Exceptional 21 years of dedicated experience as a medical writer within the pharmaceutical industry.
• An extensive portfolio indicating a comprehensive understanding of multiple diabetes-related topics, ranging from diabetic retinopathy to the initiation of insulin therapy in primary care.

Jason, a holder of a BSc Honours degree in Biochemistry and an MSc in Economic Evaluation in Healthcare, has 20 years of experience in medical writing specialising in publication management in the field. His expertise spans an impressive range of therapeutic areas including cardiology, dermatology, eating disorders, gastroenterology, oncology, psychiatry, and rheumatology. With a particular focus on Health Economics and Outcomes Research (HEOR) writing, he regularly reviews Health Technology Assessment (HTA) submissions, white papers, business cases, meeting reports, core claims, and peer-to-peer presentations. Jason also offers crucial editorial support to clinical, HEOR, and payer advisory boards.

Key Experience:

• Over 20 years in medical writing with an emphasis on publication management.
• Expertise in multiple therapeutic areas such as cardiology, dermatology, gastroenterology, oncology, psychiatry, and rheumatology.
• Extensive experience in HEOR writing, contributing to HTA submissions, white papers, business cases, and vital presentations.

Catherine carries a significant career in medical research and medical writing with a PhD in oncology. With a strong focus on liver disease, she has spent a significant part of her career preparing reviews for respected peer-reviewed journals including topics like Non-alcoholic steatohepatitis (NASH), fatty liver disease, and Hepatitis C. She is particularly skilful at preparing conference materials, product monographs, therapeutic landscape analyses, and sales training materials. Additionally, Catherine has demonstrated a track record in producing continuing medical education materials and patient education products.

Key Highlights:

• Holds a PhD in Oncology and boasts a decade of experience in medical research.
• Dedicated 12 years to medical writing with a prime focus on liver diseases like NASH, Fatty Liver disease, and Hepatitis C.
• Versatility in creating a range of materials for various purposes and skill at producing continuing medical education materials and patient education products.

Alex is a skilled medical writer specialising in neurology and pharmacology, backed by a PhD in biomedical sciences, specifically neuropharmacology, and postdoctoral training in neuropathology. Their diverse work includes manuscripts, press releases, conference coverage and continuing medical education materials centred around neurology.
Having written on neurological conditions like Alzheimer's disease, dementia, epilepsy, sleep disorders, cognitive deficits, and brain tumours, Alex also possesses an expansive understanding of subjects like stroke, aneurysms, neuroplasticity, and neuro-interventions. They have also produced significant content on pain management for conditions like rheumatoid arthritis and irritable bowel syndrome, with a recent focus on the importance of patients' perspectives in disease management and outcomes.

Key Experience:

• Boasts a PhD in biomedical sciences, specialising in neuropharmacology, and postdoctoral training in neuropathology.
• Written extensively on a range of neurology-related topics, from Alzheimer’s disease and dementia to epilepsy and sleep disorders.
• Provides a patient-focused approach to disease management, specifically in terms of pain management for conditions such as rheumatoid arthritis and irritable bowel syndrome.

Since 2006, George has utilised his medical writing skills, initially honed while working for a large pharmaceutical company and a Contract Research Organisation (CRO) in Germany, to author a range of critical regulatory medical writing texts. Over time, he has composed around 50 Clinical Study Reports (CSRs) and protocols from Phase I to IV, along with vital contributions to Investigator's Brochures (IBs), clinical summaries and pharmacovigilance documents including patient narratives, safety update reports and risk management assessment. George's expertise spans a variety of therapeutic areas such as vaccines, oncology, diabetes, dermatology, haematology, acute liver conditions, immunocompromised allergy, medical devices, autism spectrum disorder, and wound healing.

Key Experience:

• Over 15 years of medical writing experience, including an extensive portfolio including Clinical Study Reports (CSRs), protocols and pharmacovigilance documents.
• Broad knowledge across various therapeutic areas, including vaccines, oncology, diabetes, dermatology and haematology, among others.

With a PhD in Biochemistry and over two decades of experience as a medical writer/editor in the medical education sector, Olivia has made significant contributions to a wide range of publications, including meeting reports, book chapters, and product monographs across numerous indications like hypertension and heart failure. She is proficient in developing diverse types of materials in various forms of media.

Key Highlights:

• Combines a robust academic background in Biochemistry with over 20 years of industry experience in medical writing/editing.
• Diverse publication experience ranging from book chapters to meeting reports across fields such as hypertension and heart failure.
• Showcases versatility across print, video, audio, and digital media.

With over two decades of experience in medical communications, Clara is a registered pharmacist and seasoned medical writer, skilled across many therapeutic areas and project types. Throughout her extensive career with Rx, she has effectively collaborated with various pharmaceutical institutions on ongoing projects. Many of these projects have been in the field of health economics and outcomes, and include value dossiers, publications, training slide sets and HTA submissions. Recently, she has been engaged in data analysis for treatment of pancreatic cancer, lupus, cardiovascular diseases, and metabolic syndrome. Clara also played a key role in securing funding through research proposal development, proving her effectiveness as both a team and project leader.

Key Highlights:

• Over 20 years of professional experience as a pharmacist and in medical communications for different agencies and publishing entities.
• Specialises in medical writing across various therapeutic areas with a primary focus on health economics and outcomes.
• Led successful data analysis initiatives and research proposals for funding, showcasing strong leadership skills.

David boasts an extensive career spanning 32 years in the field of medical writing. His expertise covers various regulatory areas, including handling protocols, Clinical Study Reports (CSRs), patient narratives, and the creation of integrated summaries focused on efficacy and safety. David's work history is studded with notable projects surrounding the treatment of numerous ailments. He has contributed significantly to the field of oncology, dealing with pioneering treatments for breast, prostate and skin cancer. David also has invaluable experience working on the management of inflammatory diseases and acute coronary syndromes. His diverse expertise extends to the realm of ophthalmology where he has worked on advancing therapeutic antihistamines.

Highlighted Experience:

• A reputable career grounded on 32 years of experience in medical writing, emphasising various key regulatory areas such as protocols, Clinical Study Reports (CSRs), patient narratives and comprehensive summaries on efficacy and safety.
• Significant contributions to the field of oncology, having worked on pioneering treatments targeted at several types of cancer, including but not limited to breast, prostate, and skin.
• Extensive work experience surrounding the management and study of inflammatory diseases, acute coronary syndromes and advances in therapeutic antihistamines concerning ophthalmological applications.