Medical Writer - SeniorPosted: November 13, 2009
MEDICAL WRITER - Senior
Qualifications/ Requirements:
• Candidate must have Clinical Studies experience (very important)
• Candidates with the following job titles/experience may be a good fit for the position: Medical Writer, Clinical Project Manager, Clinical Research Manager, Clinical Trials Reader
• Must express him/herself clearly and possess strong communication skills to work on protocols
• Must have experience working with or in Clinical Trials
• Not looking for a specific number of years experience
• Person has to be thorough, a clear thinker and be able to put thoughts on paper
Description:
Write New Drug Application submissions and Chemistry Manufacturing & Controls materials. This Medical Writer will gather input from Scientists/Physicians and compile data into a document. Plan and prepare a variety of clinical documents (clinical study reports, investigator brochures, etc.) by organizing, analyzing, and interpreting scientific and statistical data. Prepare integrated summary documents for regulatory submissions. Participate in study teams, coordinate and conduct document-related meetings including the preparation of a pre-meeting agenda and post-meeting minutes. Review protocols, clinical data reports, and case report forms as required. Eight (8) years experience.
Overall Major Duties:
• Writing of phase I/IIa protocols in close interaction with clinical teams.
• Conduct/Prepare Phase I and Phase II Clinical Trials
• Develop/Write Protocols as part of the Clinical Trials
Additional Notes:
• Candidate may be considered for a permanent position based on performance.
• Scientific background is not as important as strong organizational and communication skills and common sense
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dinaliC is a Philadelphia based consulting firm provides consulting services to major Pharmaceutical companies in US in the areas of Scientific & Research, Clinical, Engineering, Finance & Information Technology fields.
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