Forum Topic Medical Writing
  • Conversation: Medical Writer

    • March 16, 2017 4:37 PM GMT
    • Medical Writer

      Hi All,I do have below requirement which is for our Direct client. Please let me know your are interested.Role: Medical Writer
      Location: Woodcliff
      Lake, NJ
      Duration: Contract
      Job Description:
      directly with clinical study teams, the Oncology medical writing
      teams, regulatory affairs personnel, and the publishing group in the
      preparation of scientifically valid regulatory documents. Responsibilities include
      preparation of regulatory documents on behalf of Eisai in accordance with the
      ICH guidelines, international regulations, Eisai standards and processes, and
      the Eisai Writing Style Guide as applicable. Documents include but are not
      limited to: Protocols and protocol amendments, clinical study reports,
      Investigator brochures, and submission documents. Participate in project team
      meetings to provide input regarding deliverables, timelines, and processes.
      Responsible for managing the document review process. Route documents for
      approval. The medical writer should be familiar with ICH
      guidelines and the current AMA Style Manual. The writer will be
      expected to format and manage long documents with multiple review cycles and
      tight deadlines.
      degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD
      regulatory writing skills, meticulous attention to detail, proficiency using an
      electronic document management system and standard style guide, and strong
      analytical ability to interpret clinical data.
      Experience: 5+ years’ writing experience in the
      pharmaceutical industry.
      are looking for someone with experience working as a MW for a major Pharma.
      Prior experience in oncology is a plus. The most important requirement is the
      ability to independently write regulatory documents in collaboration with the
      various members of study team.
    • March 29, 2018 12:47 PM BST
    • Good Afternoon Krish,

      I am working on a number of Medical Writing opoortunities all across Europe. With global expansion, my client is looking for candidates who have key regulatory writing experience. Once you have received this message, please do send me an email and we can talk further:



Add Reputation

Do you want to add reputation for this member by this post?

or cancel