END DATE October 23, 2016

Contract Medical Writer (QC)

Alkermes - Waltham, MA

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  • Company
    Alkermes Alkermes
  • Location
    Waltham, MA
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Company Ref #
  • AJE Ref #

Job Description

td p span span span Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com /span /span /span /p p strong style="margin: 0px; padding: 0px;" span span span Position Summary: /span /span /span /strong /p p span span span The Contract Medical Writer (QC) will be responsible for quality review of all Medical Writing deliverables to ensure accuracy and consistency of message. /span /span /span /p p span span span b Responsibilities:  /b /span /span /span /p ul li span span span Oversee number accuracy against source documents and for consistency within given document and between associated documents (for example, making sure the details of a protocol align with the SAP and IB, or making sure the messaging and details in a briefing package align with the messaging and details in applicable protocols, study reports, IBs, other regulatory submission documents, etc.) per MW SOPs and internal procedures. /span /span /span /li li span span span Compilation oversight and accuracy of CSR appendices and will ensure templates are applied consistently, and writing style is consistent across documents (within and across programs).   /span /span /span /li li span span span Basic copy editing (spelling, punctuation, grammar) and technical formatting of documents.  /span /span /span /li /ul p em style="margin: 0px; padding: 0px;" span span span Internal relationships: /span /span /span /em span span span In addition to the Medical Writing Team, this person will work closely with the Regulatory Operations group and CROs/vendors (as needed)  /span /span /span /p