This is a medical writers position that requires use of scientific knowledge and writing skills to effectively and clearly communicate. This position requires focus on scientific medical writing, which includes medical studies, drug trials and regulatory documents.
Work with cross functional teams and conduct literature searches to enhance their background understanding, and evaluate and analyze the information they will be writing about.
It ensures that all deliverables are in accordance with regulations, standards, and guidelines.
The regulatory documents that the Medical Writer prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide
Must understand the levels of evidence required to achieve regulatory, marketing and regulatory goals
Responsible compilation, writing, and editing medical and regulatory writing covering all phases of clinical research for submission to regulatory agencies or Ethics committees (i.e. clinical study reports, create summary or changes, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data, publications, etc).
Conduct adjudication meetings, maintain version control and insure timelines are agreed upon and met.
Medical Writer Skills
At least 10 year of experience in pharmaceutical development or related experience
Proficiency in Word, Excel, PowerPoint, email, and the Internet
Extensive knowledge of English grammar with a familiarity with a standard style guide
Ability to communicate scientific or medical information in a clear and concise manner
Familiarity with the principles of clinical research
Ability to interpret and present clinical data and other complex information
A strong communicator with meticulous attention to detail solid writing and organizational skills.
Ability to work well independently or as part of a team including in high-pressure situations.
Collaborative, ability to influence and reach compromises cross functionally to reach a quality document
Principia Biopharma, Inc. is an equal opportunity employer