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Monday, December 03, 2012 11:59:02 PM
Full time
Department: Clinical & Regulatory Affairs
Job Description:
Job Description
Join us in the fight against Cancer!
We are a biotech company based in Tustin California looking for a medical writer for our clinical study and regulatory project teams.
You won’t get lost in the crowd and your contribution will be recognized. As part of a small team, you will make a difference in everything we do. Your excellent writing skills will provide the team with expertise to analyze and interpret clinical and scientific information. You will be summarizing findings in an objective and concise manner to help speed the regulatory process.
Your expertise is essential for building clinical reports, investigator brochures, summary of safety and efficacy documents, and other documents that may be submitted to the Food and Drug Administration or other organizations for publication and/or presentation as we prepare to revolutionize patient therapies for brain, lung and pancreatic cancer.
We would look to your experience for the production of high-quality clinical documents to help our rapid approval process with the FDA.
In addition, you can be a part of messaging our studies to the scientific community throughout the world through the preparation of scientific manuscripts, abstracts and posters.
The right person for this role will have expert knowledge of regulatory requirements and ICH Guidelines as related to clinical writing.
Leadership in our company is demonstrated by every person not through managing people but through managing projects. This role demonstrates leadership through the ownership of the documents that this role generates and assuring they are facilitated quickly through review and approval by senior management.
Peregrine offers a wide variety of benefits to meet individual needs including medical, dental, life, 401(k) with matching, vanpools to the LA area, train tickets via payroll deduction (we are local to the Tustin MetroLink Station). We sponsor a variety of wellness and appreciation events to demonstrate our commitment to our employees.
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