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Senior Medical Writer
(Job Code: 8HR124)
Role and Responsibilities:
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, integrated regulatory summary
documents, protocols, and manuscripts. This individual creates
documents that effectively and clearly convey scientific data, ensuring
that such documents comply with regulatory, journal or other 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.
Identify the customers for each document, and formulate and convey
key messages clearly and concisely for those customers.
Understand the key components / messages for regulatory submissions as
embodied in FDA and ICH guidelines, for instance, the Clinical Expert
Report and Clinical Overview components of the Common Technical Document.
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.
Qualifications:
Minimum of 5 years of industry experience as a medical writer; an
undergraduate degree in a scientific discipline, pharmacy, or medicine
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 of 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.
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