Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
We are seeking a highly skilled and experienced Medical Writer to join our dynamic team at Ardelyx. The successful candidate will play a critical role in the development of high-quality clinical documentation in compliance with regulatory standards and internal requirements. This position offers the opportunity to work in a collaborative environment which contributes to the success of our medical information strategies and business objectives.
Responsibilities:
- Develop high quality clinical documents ensuring scientific excellence and regulatory compliance, including writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines
- Write, format, and edit clear, concise content that meets the target audience's needs, adhering to style guidelines and documentation standards (i.e., custom responses, standard response documents (SRDs), FAQs, protocols, consumer brochures, congress posters, etc.)
- Ensure compliance of clinical documents with regulatory requirements
- Provide scientific evaluation of company products to key internal stakeholders, and collaborate with cross-functional teams to implement medical-driven communication strategies
- Act as a scientific point of contact within the company, facilitating clear and effective communication of scientific information
- Prepare document timelines, with guidance from manager, as needed
- Conduct literature searches
- Summarize data from statistical tables and other sources as needed
- Coordinate quality control reviews of clinical documents and maintain audit trails of changes
- Develop clear, accurate, and visually engaging graphic content, including tables and figures, to effectively communicate scientific and clinical data in accordance with company and regulatory guidelines
- Design and develop scientific posters for congresses, ensuring accurate data presentation, clear visuals, and adherence to conference guidelines and corporate branding standards
- Review and ensure the accuracy, clarity, and consistency of all clinical documents
Qualifications:
- Master’s with 3+ years of medical writing experience in the pharmaceutical or biotechnology industry, with a strong understanding of regulatory submission requirements, or equivalent experience
- Advanced degree in scientific discipline (PhD, PharmD, MD) preferred
- Exceptional writing, editing, and formatting skills
- Detail-oriented with a focus on accuracy and precision
- Ability to interpret and summarize complex scientific data
- Excellent communication and interpersonal skills
- Proven ability to manage multiple projects and meet deadlines
- Strong organizational and project management skills
- Proficiency in graphic design software (Adobe, Microsoft Visio, GraphPad Prism, etc.)
- Ability to work independently and as part of a team
The anticipated annualized base pay range for this full-time position is $122,000-$149,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
