• Job Description

  Req#: 12550

  The Senior Medical Editor provides quality control (QC) and formatting to ensure submission readiness of clinical documents and coordinates clinical study report (CSR) appendices. Serves as a technical resource for questions regarding Alkermes procedures for QC, submission readiness, and CSR appendices. Acts as the medical writing expert for formatting documents according to Alkermes editorial style for regulatory documents.

  Qualifications

  • A strong command of the English language (vocabulary, grammar, spelling) is required.
  • Minimum three years of experience in QC and submission readiness of clinical documents (protocols, IBs, CSRs).
  • Requires high proficiency in Microsoft Word and familiarity with StartingPoint or similar formatting software.
  • Familiarity with medical or scientific documentation is required, preferably in neuroscience.
  • Communicates effectively. Able to adapt to shifting project timelines. Strong attention to detail. Collaborates with team members to share information, resources, and tools, and cultivates productive working relationships with peers. Proactively identifies problems and knows when to escalate issues.

  Requirements for Job (Years of Experience, Education, Certifications):

  • A minimum three years of experience in similar role is required.
  • B.S / B.A. is required

  #LI-VG

  Responsibilities

  • Familiar with GCP and ICH guidances for standard clinical documents (eg, protocol, Investigator’s Brochure [IB], and CSR). Familiar with AMA style guide. Expert with Microsoft Word. Proficient with EndNote and StartingPoint software. Good command of document management and document revision software. Familiar with clinical research documentation, department systems, and SOPs, as appropriate.
  • Provides primary quality control of clinical documents, including verification of data against source documentation and identification of errors. Identifies text that requires revisions or additions and suggests new text. Responsible for updates and improvements to the QC checklists.
  • Fully edits clinical documents to ensure they are submission ready and compliant with the Alkermes Regulatory Submission Style Guide and all applicable regulatory formatting requirements. Serves as an editorial resource for questions regarding formatting in Microsoft Word and the use of the StartingPoint Author toolbar. Responsible for updates and improvements to the submission readiness checklist.
  • Supports the development of CSRs as part of the CSR team. Acts as the owner of the CSR content strategy map (map of all CSR appendices and content owners). Supports CSR content owners with the finalization of appendices. Ensures all CSR appendices are submission ready prior to publication. May support improvements to the CSR compilation process.
  • May occasionally participate in medical writing tasks and process improvement initiatives.

• About the company

  Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology.

Notice