Ardelyx is looking for a Medical Writer to join our team. You will develop high-quality clinical documentation in compliance with regulatory standards, playing a critical role in our medical information strategies and business objectives. This position offers the opportunity to work in a collaborative, dynamic environment.
What You'll Do
- Develop high-quality clinical documents ensuring scientific excellence and regulatory compliance.
- Write, format, and edit clear, concise content for various materials, adhering to style guidelines.
- Ensure compliance of clinical documents with regulatory requirements.
- Provide scientific evaluation of company products to key internal stakeholders.
- Collaborate with cross-functional teams to implement medical-driven communication strategies.
- Act as a scientific point of contact within the company.
- Prepare document timelines, with guidance from manager, as needed.
- Conduct literature searches and summarize data from statistical tables as needed.
- Coordinate quality control reviews of clinical documents and maintain audit trails.
- Develop clear, accurate, and visually engaging graphic content, including tables and figures.
- Design and develop scientific posters for congresses.
- Review and ensure the accuracy, clarity, and consistency of all clinical documents.
What We're Looking For
- Master’s degree with 3+ years of medical writing experience in the pharmaceutical or biotechnology industry.
- 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.
- Proficiency in graphic design software (Adobe, Microsoft Visio, GraphPad Prism, etc.).
- Ability to work independently and as part of a team.
Nice to Have
- Advanced degree in scientific discipline (PhD, PharmD, MD).
Technical Stack
- Adobe
- Microsoft Visio
- GraphPad Prism
Benefits & Compensation
- Compensation: $122,000-$149,000 + equity awards, subject to eligibility.
- 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 shutdown.
- At least 11 paid holidays.
Ardelyx is an equal opportunity employer.
