Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically-oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, agency RTQs, and eCTD summary documents for IND, NDA, MAA, BLA and biosimilar BLA applications and amendments.
Interpret data, search and analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
Manage and direct client project teams, including identifying... directing, and delegating tasks necessary for successful document completion.
Interact directly with clients and contractors; participate in and lead discussions during meetings.
Collaborate with project teams to respond to heath authority questions and requests.
Collaborate and help other medical writers in the writing, editing, QC review and compilation of documents.
Prepare and manage project plans and timelines.
Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously and reorganize and reschedule work as needed in order to meet client deadlines.
Understand and support the nature of the business and the company’s commitment to quality and responsiveness.
Proactively develop/maintain technical knowledge, remain up-to-date on current trends and best practices; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance.
PhD, PharmD, MS, BS, RN, or RPh in a relevant scientific or pharmaceutical discipline
10+ years of experience in the Pharmaceutical industry with 6+ years of experience in medical/regulatory writing/editing required.
Experience with biosimilars and BLAs preferred.
Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles.
Understanding of medical terminology and statistical methodology is a must.
Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries for INDs, NDAs, BLAs, and integrated summaries of safety and efficacy.
Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as edit on all levels, from copy editing to major rewriting.
Experience and proficiency with document templates and proper version control.
Demonstrated leadership capability with good team player characteristics.
Excellent communication and interpersonal skills.
Strong project management skills.
Must be organized and self-motivated with strong attention to detail