part time senior tech

Job Details

Remote Senior Medical Writer

  • Employee Type: Contract
  • Job #: 1095484
  • Apex Systems is seeking a Senior Medical Writer to work remotely and must be based in the U.S.
  • For immediate consideration, please email Nick, at nkreutz@apexsystems.com.

Responsibilities:

  • 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.

Qualifications:

  • 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

See something wrong with this listing?

Contact support