Thursday, September 8, 2016

C2C :: Medical Writer - Edison, New Jersey

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Dear Partners/Job Seekers

We have a Corp to Corp opening for Medical Writer in Edison, New Jersey, if you have matching candidates please submit their profiles here.

Candidates matching the requirements will be contacted.


Hi,

Hope you are doing well,

We are looking for a Medical Writer for a contract position at Edison, New Jersey. Please review below job details and send me your most updated profile, Appreciate if you can refer your friends or colleagues who might be looking for a job.

Title: Medical Writer

Location: Edison, New Jersey

Duration : 8-10 Months

Openings: 4 Positions

JOB DESCRIPTION:

Job Description for Medical Writer:

Experience required: 10-12 years.

• Prepare documents that present clinical data objectively in a clear, concise format. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical documents like

  • Summary Documents
  • eCTD Submission Documents
  • Clinical Overview
  • Safety & Efficacy reports
  • Risk Management Plan
  • Development and updating of Investigator's Brochures, Clinical Study Protocols, and other regulatory documents
  • Analysis, interpretation, and accurate presentation of information or data in text, table, or figure format
  • Provide dedicated scientific authoring expertise to both the development and research groups.
  • May need to liaise with external services and review documentation generated elsewhere (e.g., Clinical Research Organizations [CROs], subsidiaries, co-development partners), and internal support staff (e.g., for the preparation of tables, illustrations, and appendices).
  • Quality-checking documents for agreement between in-text information and the source data
  • Prepare reports, manage review cycles, and incorporate comments as appropriate.
  • Provision of overall medical writing support for ongoing programs
  • Scientific degree, preferably PhD, or medically qualified, or with equivalent relevant experience.
  • Experience (preferably 7+ years) as MW, or equivalent, or presenting relevant qualifications.
  • Experience Preferred in Therapeutic areas like - Oncology, Neurology, Cardiovascular (Not Mandatory)
  • Very good verbal and written English skills
  • High degree of accuracy with attention to detail
  • Excellent analytical and problem solving skills
  • Good level of computer literacy, in particular in the use word, excel and databases
  • Personal skills: good communication, presentation, flexibility, time management and
  • Ability to work independently and proactively within a team.
  • Ability to work on multiple projects simultaneously, while maintaining

Qualifications:


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