Not Synergistech’s Jobs

Department: Clinical Research

Description:

Primary responsibility is to write, edit and review clinical documents for submission to regulatory agencies, eg, FDA, according to ICH guidelines.

Duties and Responsibilities:

• Participate as a member of cross-functional teams to write, edit, and review clinical/regulatory documents, including study protocols and amendments, clinical study reports. Investigator Brochures, integrated safety and efficacy summaries, clinical portions of FDA briefing documents, and other documents that support IND/NDA/eCTD applications.
• Develops and manages timelines of writing projects from inception through final signature.
• Establishes and maintains document standards, styles, and formats according to ICH guidelines.
• Reviews and edits documents for compliance, consistency, clarity, and accurate use of scientific terminology; facilitates discussion in the case of conflicting interpretations.
• Interacts with clinical, preclinical, biometry, regulatory, and scientific staff to obtain analytical information and data necessary to complete documents and projects.
• May collaborate with medical writing consultants on specific writing projects, eg, clinical study reports, to facilitate collection of data and study information, routing of reviews, and finalization and approval of the document.
• May also edit or write abstracts, manuscripts, slide and poster presentations, and investigator newsletters, as needed.
• Other duties may be assigned.

Job Requirements:

• Master’s or Ph.D. in a biological or biomedical science (eg, Biology, Immunology, Chemistry, Pharmacology, or Nursing). A master’s degree in English or journalism, with additional science and technical or medical writing coursework may be acceptable in lieu of a science degree.
• Minimum of 5 years of medical writing experience in a regulated environment (eg, pharmaceutical or biotechnology company, contract research organization), or university medical center, hospital, or research institute. A bachelor’s degree in a scientific discipline may be acceptable with a minimum of 8 years of medical writing experience.
• Experience in preparation of clinical/regulatory documents for U.S. regulatory submissions; experience with ex-U.S. regulatory documents is a plus.
• Excellent interpersonal, organizational, and communication skills; detail oriented.
• Ability to manage and prioritize multiple ongoing projects from conception to completion, and work in a team environment.
• Ability to work with little or no instruction on routine work and general instructions on new assignments.
• Understand good clinical practices (GCPs) and relevant ICH guidelines, specifically those governing the creation and submission of clinical study reports, protocols, Investigator’s Brochures, and other clinical/regulatory documents such as the Common Technical Department.
• Ability to analyze and synthesize date from a broad range of disciplines; produce clearly written scientific documents.
• Proficiency with Microsoft® Office Applications, particularly MS Word, Excel, PowerPoint, and Outlook.
• Ability to prepare graphic presentations of data using Excel, Visio, or other graphic software is a plus.

Anesiva is an equal employment opportunity employer and promotes diversity throughout its workforce. Applications and resumes are considered for all positions without regard to race, color, religion, sex, national origin, ancestry, age, medical condition, physical or mental disability, marital status, sexual orientation, or veteran status.

To apply:
http://www.anesiva.com/wt/page/current_opportunities/job/1214_001/apply