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 submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Description
We are seeking a highly skilled and experienced Senior 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
-
With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes 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.
-
Clinical documents may include investigator brochures, standard response documents (SRDs), FAQs, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations, manuscripts/abstracts for publication and/or presentation.
-
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.
-
Review and ensure the accuracy, clarity, and consistency of all clinical documents.
Qualifications
-
Advanced degree in a scientific discipline (PhD, PharmD, MD) preferred; Master’s degree with significant relevant experience considered.
- Minimum of 3-5 years of medical writing experience in the pharmaceutical or biotechnology industry, with a strong understanding of regulatory submission requirements.
- 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.
-
Ability to work independently and as part of a team.
Location
-
Remote position with up to 15% travel to meetings throughout the year.
As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients. It’s the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines. We are different for good.
The anticipated annualized base pay range for this full-time position is $106,000- $120,790. 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.