Senior/ Principal Medical Writer (12-136) FibroGen
THIS JOB HAS EXPIRED Description:
The Senior Medical Writer is responsible for writing, editing, and/or reviewing clinical documents including, but not limited to, clinical study reports, investigator?s brochures, protocols, and integrated regulatory summary documents. This individual creates documents that effectively and clearly convey scientific data, ensuring that such documents comply with regulatory guidelines in terms of content, structure, and style. Additional responsibilities include the following:
Write high-quality clinical documents that support FibroGen?s goals and objectives.
Understand the key components/messages for regulatory submissions as embodied in FDA and ICH guidelines.
Identify the customers for each document, and formulate and convey key messages clearly and concisely for those customers.
Keep current with therapeutic area(s) relevant to assigned projects.
Use appropriate FibroGen stylistic conventions.
Keep up-to-date on the software needed for this position.
5 ? 8 + years of industry experience as a pharmaceutical medical writer; an undergraduate degree in a scientific discipline is preferred; an advanced scientific degree is a plus.
Knowledge of, or aptitude for understanding, medicine; familiarity with the drug development process and regulatory documentation.
Ability to gather and synthesize large amounts of data.
Demonstrated ability to write clear, concise, and effective drug development documents, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately.
Understanding the role of various documents relevant to drug development in an international environment.
Good team player; excellent written and verbal communication skills, and the ability to work well with others.
Proven document planning and project management skills.
Ability to meet timelines without compromising document quality.
Ability to communicate with professionals from many functional disciplines and to work across teams (often remotely).
Ability to ensure consistency within and across documents to avoid confusion.
Competency in relevant software applications.
Mandarin technical writing skills is a plus.
||San Francisco, CA |
THIS JOB HAS EXPIRED