Education/Experience Qualified candidates must have a PharmD, PhD in biological sciences. MD is strongly preferred. Otherwise exceptional candidates with a MS or BS/BA may be considered. Minimum requirement of 3 years experience with PharmD or PhD, 5 years with Masters’ Degree or 7 years with a BA/BS. Experience in writing regulatory documents (protocols, Investigator Brochures [IBs], Clinical Study Reports (CSRs), clinical sections of the CTD [2.5, 2.7.3, 2.7.4], integrated summaries of efficacy and safety [ISE and ISS], briefing books, and regulatory responses) in the pharmaceutical or CRO environment required; ability to interpret and organize scientific data; and general understanding of clinical research, biostatistics, electronic publishing, and relevant industry guidelines (GCP, eCTD, and ICH). Marketing submission experience (NDAs or MAAs) preferred but not required. Daiichi Sankyo develops or has developed drugs in the following therapeutic areas: cardiovascular diseases, metabolic diseases, inflammation and immunology, infectious diseases, and oncology. Relevant therapeutic area experience preferred. Ability to quickly get up to speed on a therapeutic area, project, or indication with little to no coaching, work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as the situation demands. Strong interpersonal and communication skills (both verbal and written) are also required as the individual must be able to work in a team environment and coordinate with the team to move documents forward to completion. Must be a self-motivated person who can work with limited guidance/supervision. Excellent writing skills with a clear concise style and excellent grammar, punctuation, and spelling; proficiency in a Microsoft Windows environment; and strong MS Word skills and ability to work with templates. Excellent attention to details, especially as related to accuracy of numbers/statements and consistency within and across documents. |
