Please direct your responses to: cbrooks@pcyc.com
Pharmacyclics is a mid-sized company that designs, develops and commercializes novel Therapies intended to improve the quality of life and increase the duration of life while resolving serious medical healthcare needs. Our products are based on exceptional development expertise.
This position is responsible for working with the Pharmacyclics Development Operations Group to produce clinical documents including, but not limited to, clinical study protocols and amendments, informed consents and other documents to support clinical trials, as well as to manage the joint document review process between Pharmacyclics and alliance partners.
Key Accountabilities/Core Job Responsibilities:
• Prepare clinical documents such as clinical study protocols, protocol amendments, and summary of changes in collaboration with Clinical Science, ICFs, and other clinical documents as assigned in-line with regulatory requirements and PCYC internal document standards.
• Work collaboratively with functional contributors (Clinical, Biometrics, Research, Regulatory Affairs, etc), ensuring accuracy and completeness, and in accordance with project timelines.
• Manage documents that require joint review by Pharmacyclics and the alliance partner(s) including, but not limited to protocols, IB, DSUR, and other project related documents.
• Work closely with the counterpart at alliance partners in identifying a process owner to coordinate completion of review including distribution, incorporation of comments, and chairing review meetings, to finalize the above listed documents.
• Proofread and QC clinical and regulatory documents as assigned.
• Fact check literature references in protocols, and other documents; prepare and format reference lists.
• This person will serve as a cross-functional resource.
Education, Qualifications and Requirements:
• Advanced degree in life sciences (MS or PhD) with 3 years of relevant experience in a medical writing/clinical submissions environment; or a BS degree and minimum 5 years of relevant experience within clinical R&D or regulatory affairs in pharmaceuticals/biotechnology industry.
• Well developed computer skills including proficiency in MS Word, Excel, Power Point and Adobe.
• Excellent verbal communication skills.
• Knowledgeable of regulatory document requirements/guidelines.
• Excellent proofreading, copy editing, and written and verbal communication skills; careful attention to detail.
• Familiarity with AMA style is a plus.
• Ability to manage multiple projects on tight timelines with minimum supervision.
Pharmacyclics is an Equal Opportunity Employer
This position is responsible for working with the Pharmacyclics Development Operations Group to produce clinical documents including, but not limited to, clinical study protocols and amendments, informed consents and other documents to support clinical trials, as well as to manage the joint document review process between Pharmacyclics and alliance partners.
Key Accountabilities/Core Job Responsibilities:
• Prepare clinical documents such as clinical study protocols, protocol amendments, and summary of changes in collaboration with Clinical Science, ICFs, and other clinical documents as assigned in-line with regulatory requirements and PCYC internal document standards.
• Work collaboratively with functional contributors (Clinical, Biometrics, Research, Regulatory Affairs, etc), ensuring accuracy and completeness, and in accordance with project timelines.
• Manage documents that require joint review by Pharmacyclics and the alliance partner(s) including, but not limited to protocols, IB, DSUR, and other project related documents.
• Work closely with the counterpart at alliance partners in identifying a process owner to coordinate completion of review including distribution, incorporation of comments, and chairing review meetings, to finalize the above listed documents.
• Proofread and QC clinical and regulatory documents as assigned.
• Fact check literature references in protocols, and other documents; prepare and format reference lists.
• This person will serve as a cross-functional resource.
Education, Qualifications and Requirements:
• Advanced degree in life sciences (MS or PhD) with 3 years of relevant experience in a medical writing/clinical submissions environment; or a BS degree and minimum 5 years of relevant experience within clinical R&D or regulatory affairs in pharmaceuticals/biotechnology industry.
• Well developed computer skills including proficiency in MS Word, Excel, Power Point and Adobe.
• Excellent verbal communication skills.
• Knowledgeable of regulatory document requirements/guidelines.
• Excellent proofreading, copy editing, and written and verbal communication skills; careful attention to detail.
• Familiarity with AMA style is a plus.
• Ability to manage multiple projects on tight timelines with minimum supervision.
Pharmacyclics is an Equal Opportunity Employer
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