Medical/Scientific Writer (FT, Baltimore)

Job Title:
Medical/Scientific Writer, biopharmaceutical company

Full-Time, Baltimore, MD

Position Summary:

The Medical/Scientific Writer will be responsible for working with multidisciplinary technical functions to support writing and/or editing needs. This individual will support the writing, review and revision of clinical, discovery and other technical documents related to the drug development process.

Essential Functions/Responsibilities:
– Write and/or provide editorial support for clinical documents including protocols, investigator’s brochures, clinical study reports, clinical summaries of safety and efficacy and other documents necessary for regulatory submission and for publication and/or presentation
– Interact with and provide writing and/or editorial assistance to scientific staff to produce technical documentation including grant proposals, scientific manuscripts and other reports
– Analyze and interpret scientific and statistical data for continuity of submission
– Assist in non-technical writing projects related to corporate communications or other business needs as required
– Ensure timely preparation and transmittal of submissions and full compliance with applicable regulatory and company guidelines and processes

Requirements:
– BS/MS in a scientific discipline
– Minimum of 3 years experience in technical writing in biotech or pharmaceutical industries
– Working knowledge of FDA and ICH regulations and guidelines
– Superior writing skills
– Ability to analyze data from a broad range of disciplines
– Excellent interpersonal skills
– Ability to successfully coordinate team efforts across a number of technical functions in order to meet internal and external deadlines for completion
– Proficiency with Microsoft Office applications

Please send resumes to: bhorvat@criticalpathinc.net

Contact: Beverly Horvat, Recruiter, 412-851-4144 X16

$100K plus bonus, stock options, relocation assistance, etc.

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