Medical Writer *Contribute to clinical, nonclinical, and regulatory documents according to applicable regulations. Clinical documents will include protocols, Investigator’s Brochures, consent forms, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of IND’s, NDA’s, and other regulatory submission documents. In addition, this role may assist in authorship of abstracts,
posters and manuscripts, and patient education materials.
Location: San Francisco, CA (not virtual)
No Relocation
Description:
• Work with clinical team to prepare protocols, study reports, investigator brochures under strict timelines.
• Work with the nonclinical team to prepare nonclinical reports, and nonclinical sections of various documents
• Work with Regulatory Affairs department to prepare regulatory documents
• Ensure efficient formatting of documents; ensure a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier and briefing package / book.
• Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions.
Qualifications:
• PhD in a Life Science or equivalent
• Demonstrated ability to communicate and write English clearly, concisely, and effectively
• Grant and publication writing would be a plus
• Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines
• Working knowledge of drug / biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
• Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents and annual reports would be a plus
• Accurate and detail-oriented
• Aptitude for compilation, analysis, and presentation of data
• Independently motivated, and good problem-solving ability
• Ability to work with multiple contributors to produce a final unified document
• Enjoy a cohesive, motivated team-oriented work environment.
***Send Resume TODAY!
posters and manuscripts, and patient education materials.
Location: San Francisco, CA (not virtual)
No Relocation
Description:
• Work with clinical team to prepare protocols, study reports, investigator brochures under strict timelines.
• Work with the nonclinical team to prepare nonclinical reports, and nonclinical sections of various documents
• Work with Regulatory Affairs department to prepare regulatory documents
• Ensure efficient formatting of documents; ensure a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier and briefing package / book.
• Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions.
Qualifications:
• PhD in a Life Science or equivalent
• Demonstrated ability to communicate and write English clearly, concisely, and effectively
• Grant and publication writing would be a plus
• Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines
• Working knowledge of drug / biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
• Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents and annual reports would be a plus
• Accurate and detail-oriented
• Aptitude for compilation, analysis, and presentation of data
• Independently motivated, and good problem-solving ability
• Ability to work with multiple contributors to produce a final unified document
• Enjoy a cohesive, motivated team-oriented work environment.
***Send Resume TODAY!