Xinjiang Syd. W. Email & Phone Number

A seasoned medical writer specialized in both regulatory writing and publication management in TAs of immune-oncology, autoimmune diseases, neurology, psychology and metabolic diseases.PROFESSIONAL GOALTo apply my broad knowledge and experience in medical writing, scientific communications and clinical/regulatory science in developing medicines to improve health and cure human diseases.QUALIFICATION HIGHLIGHTS• Management experience as head of a team with regulatory writers and publication mangers supporting a pipeline with >20 drugs in therapeutic areas of oncology, metabolic diseases, autoimmune diseases and ophthalmology in a top biotech.• 10 year experience (6 year management) in medical writing, translational/clinical research, and publication management in pharmaceutical/biotech/Science-communication industry with expertise in the fields of oncology, neuroscience, diabetes, gout and autoimmune diseases.• Regulatory writing experience including Protocols, Clinical Study Reports, Investigational Brochures, Clinical Overview, Clinical Summaries, FDA meeting packages, various regulatory dossiers for US FDA expedited programs, drafting of answers to regulatory authorities (FDA/EMA/NMPA). • Extensive experience as function lead or principal medical writer in major regulatory submissions to FDA (2 INDs, 3 BLA), EMA/FDA (2 orphan drug designation applications) and NMPA (5 INDs and 4 NDAs).• Extensive experience of publication management in biotech and academic settings with publication records (Lancet Rheumatology, Kidney International, and Arthritis & Rheumatology etc.)• Extensive working experience in a multi-disciplinary team environment with excellent interpersonal skills as well as the supervisory experience of independent project champions.

Listed skills include Cancer, Cell, Medical Writing, Pharmacology, and 31 others.