Medical Writer
Job Title: Medical Writer
Company: XenoPort, Inc
Status: Full Time
Years of Experience: 8+
Location: Santa Clara, CA
Description:
We are currently seeking an individual to become a member of our growing team in providing expertise with developing, writing, reviewing, and editing clinical development documents, including but not limited to clinical protocols, Investigator Brochures, clinical study reports (full report and synopses), subject consent forms, abstracts, and publications to medical journals through collaboration with clinical researchers and regulatory scientists.
Responsibilities:
·Integrate various sources of scientific information into a uniform style and language for regulatory compliance.·Coordinate internal review and QC of documents as well as with CROs and business partners.·Support the PI, Regulatory Affairs and other collaborators in the development of sections for initial IND submissions (CMC, Pharmacology/Toxicology) and IND Annual Reports.·Compose abstracts, manuscripts, and power point slides from source data output provided by researchers for presentations and publications in scientific journals.·When lead clinical development program advances to registration, work with partners, researchers, and project managers to develop an NDA consistent with FDA/ICH norm for worldwide registrations.·Strengthen the efficiency of the company internal document management system for audit and document record keeping purpose. Qualifications and Other Required Knowledge and Skills:·A Masters/PhD degree from an accredited college or university in biological/biomedical science, or equivalent experience is required. ·Minimum of 8 years experience in a pharmaceutical, biotechnology and/or clinical environment including a minimum of 3 years medical and regulatory technical writing/editing.·Must be able to function independently with minimal guidance and/or collaboratively within a team setting.·Demonstrate highly effective problem-solving, planning and organizational skills.·Effectively communicate both verbally and in writing with demonstrated expertise with grammar, syntax, and format.·Demonstrated ability to write and edit clear, concise clinical document compliant with FDA and ICH guidelines, as well as all practices and procedures related to medical writing.·Proficiency in word processing systems, i.e., Microsoft Word, MS Office or similar systems.·Must be familiar with document management systems and up-to-date on regulations such as FDA, CHMP (EU), ICH guidelines and current good clinical practices.·Must have experience and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols, INDs).
Contact Information:
Contact Name: Human Resources
Contact Email: jobs@xenoport.com
Contact Phone: 408.616.7200
Company: XenoPort, Inc
Status: Full Time
Years of Experience: 8+
Location: Santa Clara, CA
Description:
We are currently seeking an individual to become a member of our growing team in providing expertise with developing, writing, reviewing, and editing clinical development documents, including but not limited to clinical protocols, Investigator Brochures, clinical study reports (full report and synopses), subject consent forms, abstracts, and publications to medical journals through collaboration with clinical researchers and regulatory scientists.
Responsibilities:
·Integrate various sources of scientific information into a uniform style and language for regulatory compliance.·Coordinate internal review and QC of documents as well as with CROs and business partners.·Support the PI, Regulatory Affairs and other collaborators in the development of sections for initial IND submissions (CMC, Pharmacology/Toxicology) and IND Annual Reports.·Compose abstracts, manuscripts, and power point slides from source data output provided by researchers for presentations and publications in scientific journals.·When lead clinical development program advances to registration, work with partners, researchers, and project managers to develop an NDA consistent with FDA/ICH norm for worldwide registrations.·Strengthen the efficiency of the company internal document management system for audit and document record keeping purpose. Qualifications and Other Required Knowledge and Skills:·A Masters/PhD degree from an accredited college or university in biological/biomedical science, or equivalent experience is required. ·Minimum of 8 years experience in a pharmaceutical, biotechnology and/or clinical environment including a minimum of 3 years medical and regulatory technical writing/editing.·Must be able to function independently with minimal guidance and/or collaboratively within a team setting.·Demonstrate highly effective problem-solving, planning and organizational skills.·Effectively communicate both verbally and in writing with demonstrated expertise with grammar, syntax, and format.·Demonstrated ability to write and edit clear, concise clinical document compliant with FDA and ICH guidelines, as well as all practices and procedures related to medical writing.·Proficiency in word processing systems, i.e., Microsoft Word, MS Office or similar systems.·Must be familiar with document management systems and up-to-date on regulations such as FDA, CHMP (EU), ICH guidelines and current good clinical practices.·Must have experience and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols, INDs).
Contact Information:
Contact Name: Human Resources
Contact Email: jobs@xenoport.com
Contact Phone: 408.616.7200
posted by Alex at
11:16 PM
