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Randstad Technical Editor in Lexington, Massachusetts

Technical Editor

job details:

  • location:Lexington, MA

  • salary:$98 per hour

  • date posted:Tuesday, September 10, 2019

  • experience:Experienced

  • job type:Temp to Perm

  • reference:S_797584

  • questions:alyssa.wyson@randstadusa.com617-3490200

job description

Technical Editor

The Clinical Technical Editor will be required to edit and format clinical documents intended for submission to regulatory agencies to

meet Shire submission-ready standards. This role will also require that the Clinical Technical Editor support Clinical Editors in their

Quality Control (QC) review of documents in accordance with company SOPs and processes to ensure documents meet required

standards.

Responsibilities:

? Format clinical documents intended for submission to regulatory agencies

to meet company?s submission-ready standards

? Format ad hoc documents as appropriate

? Reference management (obtaining copyright clearance, managing

reference database, formatting of references to meet submission-ready

standards)

? Routine editing activities (abbreviations checks, in-text cross-referencing,

other activities as required)

? May assist clinical publishers in reviews of hyperlinks and bookmarks on

published clinical documents

Working hours: 9:00 AM - 5:00 PM

Skills:

  • Bachelor's degree or equivalent experience preferred

  • MUST 1-3 years in the pharmaceutical industry and specifically within a clinical R&D or regulatory operations function

preferred

  • Previous hands-on experience with regulatory submission documents preferred

Education:

Bachelors

Experience:

Experienced

Qualifications:

? Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat; EndNote experience

highly preferred

? Experience using literature search tools such as PubMed, Google Scholar, RightFind

? Meticulous attention to detail

? Meticulous attention to detail

? Ability to review documents for technical specifications

? Experience in the use of Documentum or similar Electronic Document Management system

? Familiarity with clinical documents such as study protocols, clinical study reports, investigator brochures, and other clinical

and regulatory document types

? Ability to work independently and as an integral part of a team, take initiative, and complete tasks to deadlines

? Ability to manage multiple activities, prioritize effectively, and work to aggressive timelines

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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