Freelance Medical Writer
Location : Princeton, NJ
Post Date : April 27, 2017
Employment Type : Freelance
Job Order Number : 02760-9500410853
Description :Our client in the medical device industry is seeking an experienced Freelance Medical Writer for a 6 month position.
The Freelance Medical Writer will collaborate with internal teams to write, review, edit, and track various technical documents such as clinical evaluation reports, clinical study reports, publications/manuscripts, health hazard risk assessments/risk-benefit analysis, brochures, annual reports to regulatory agencies, and literature review/report for marketing support.
Primary responsibilities are to:
Manage the document writing process by collaborating with internal and external personnel for various global clinical affairs and regulatory support documents
Create new content and make changes/edits to existing content
Analyze data from various sources; able to analyze, interpret, and critically evaluate clinical and nonclinical data and communicate to technical and non-technical stakeholders
Prepare pre-clinical and clinical sections for regulatory documentation
Develop tools and templates and ensure template sections of documents remain current and consistent across documents/business units as applicable
Develop and maintain tools to track document status to ensure reporting requirements are met
Manage and track the authoring and submission of manuscripts and publications to various journals and conferences
Develop posters, slides, and supporting materials as required
Maintain basic to advanced knowledge of the businesses products and the therapies in which they are used
Maintain general knowledge of industry, regulatory, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects
Develop and maintain effective working relationships with co-workers, internal customers, and external vendors
Requirements :Bachelor's Degree in scientific discipline or equivalent experience is required
PhD in a scientific discipline preferred
At least 5 years medical writing experience
Experience preparing drug safety documents
Strong medical writing skills and good interpersonal skills to interact effectively within team and matrix work settings
Excellent written/oral communication skills and highly proficient word processing skills
Working knowledge of regulatory guidances (such as ICH, EMA, and FDA)
Ability to multi-task, deal with competing priorities, meet aggressive timeline/quality expectations
Proficiency in Microsoft Office Suite
FOR CONSIDERATION PLEASE SEND RESUME, COVER LETTER, AND AVAILABILITY TO [email protected]
Apply for this job now or contact our branch office at 1.888.846.1668 to learn more about this position.
All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada.
© 2017 The Creative Group. A Robert Half Company. An Equal Opportunity Employer M/F/Disability/Veterans.
Princeton, NJ 08540