![]() ![]() + Minimum of 5 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. + Bachelor’s degree with 10+ years or MS with 8+ years or PhD with 5+ years of relevant career experience. + Provides guidance for medical writing processes, standards, and initiatives. Provides feedback to their managers on development plans and performance reviews. + Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. + Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve. Works collaboratively with colleagues across functions to achieve results. + Guides and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules). Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines. + Produces high-quality and timely documentation in line with expectations. Represents functional area in cross-functional team (either internally or externally). + Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. + Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation. ![]() In this role the Principal Medical Writer: The Principal Medical Writer is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to achieve goals. We rely on expert skills and inventiveness that contribute to solutions to the most pressing health challenges. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, and innovative medicine. Our Medical Writers are integral to helping bring medical breakthroughs to the world. Our Medical Writing Department strives to be the premier regulatory documentation organization in the bio-pharmaceutical industry. Our focus is on innovation and launch execution excellence we translate breakthrough science into innovative medicines that help people with cancer across the globe. ![]() Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law. Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. ![]() Principal Medical Writer, Oncology (Remote)Īt Merck in Little Rock, Arkansas, United States ![]()
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