Ardelyx is a rapidly emerging biotech company. We develop therapeutics acting in the gastrointestinal tract, and our technology relies on non-absorbable small molecules with highly specific modes of action to address unmet needs with emphasis in the cardio-renal area.
We are seeking a skilled senior medical writer with experience in publications and scientific communications for an exciting opportunity in our Fremont location.
• Prepare documents that present clinical data objectively in a clear, concise format. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical regulatory documents.
• Provide dedicated scientific authoring expertise to both the development and research groups.
• May need to liaise with external services and review documentation generated elsewhere (e.g., Clinical Research Organizations [CROs], subsidiaries, co-development partners), and internal support staff (e.g., for the preparation of tables, illustrations, and appendices).
• Scientific degree, preferably PhD, PharmD, or medically qualified, or with equivalent relevant experience.
• Experience (preferably 5+ years) as MW, or equivalent, or presenting relevant qualifications.
• Skills that are prerequisite for a medical writer (including: appropriate mastery of English, ability to coordinate multidisciplinary teams, respect of deadlines and management of priorities while respecting quality needs, etc.).
• Ability to clearly, accurately, and concisely prepare all types of clinical regulatory documentation, including major submission and/or complex documents in English.
• Proven level of excellent spoken and written English, including understanding of English language usage and also standardized writing styles.
• Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
• Ability to work independently and proactively within a team.
• Ability to work on multiple projects simultaneously, while maintaining priorities and high quality results.
At Ardelyx, you will experience an innovative and dynamic research environment. We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research.
For consideration, please send your Resume/CV and cover letter indicating Senior Medical Writer, Req#6008 in the subject line by clicking Apply Now.
Ardelyx, Inc. is an Equal Opportunity Employer.