Contract Medical Writer

Our client is currently seeking a Contract Medical Writer.
SUMMARY OF POSITION The Contract Medical Writer will focus on the preparation, assembly, writing, and review of the analyses and documentation needed in support of clinical trials and corresponding submissions to regulatory authorities.
MAJOR ACTIVITIES AND RESPONSIBILITIES Responsibilities may include but are not limited to:
o Assist with development and updating of Investigator's Brochures and other regulatory documents o Preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs and their supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc.
in a clear and accurate manner consistent with the target audience and regulatory requirements.
o Consolidation and evaluation of teammates' review comments to determine needed revisions o Reviewing statistical analysis plans and accompanying table and listing shells for the evaluation and presentation of clinical trial data o Quality-checking documents for agreement between in-text information and the source data o Editorial review of documents for grammar, punctuation, and submission-compliant formatting o Provide overall medical writing support for ongoing programs Reliance on instructions, templates, and pre-established guidelines will be expected to perform the above functions.
ORGANIZATIONAL STRUCTURE The Medical Writer Contractor reports to the Manager, Medical Writing.
QUALIFICATIONS AND BACKGROUND REQUIREMENTS Educational Requirements o Masters degree in a scientific discipline plus a minimum of 2-5 years industry experience.
o Ph.
D, Pharm.
D, or equivalent in a scientific discipline plus a minimum of 1-2 years industry experience.
Professional Work Experience o The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication.
o A good understanding of medical terminology is also needed.
o This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians.
It will be essential to approach issues from a number of perspectives, summarizing data to draw a conclusion.
o Applicant must be able to prepare deliverables in accordance with pre-established timelines, systematically performing activities in a timely and accurate manner.
o Advanced writing and speaking competency, positive and proactive communication skills, proficiency with Microsoft Office Suite.
o High attention to detail.

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