Principal Medical Writer, Clinical Affairs

As a Principal Medical Writer at Natera, you will be responsible for leading the development of various clinical documents such as Clinical Performance Study Plans (CPSPs), Investigator's Brochures (IBs), and Performance Study Reports (PSRs). Your role will involve collaborating with cross-functional teams and external partners to ensure that the documentation meets global regulatory requirements, particularly under IVDR. Additionally, you will provide subject matter expertise in clinical study design and evidence generation.

To qualify for the Principal Medical Writer role at Natera, candidates should possess a Bachelor’s degree in a relevant scientific or medical field, with an advanced degree preferred. You'll also need 8–12+ years of experience in medical writing or a closely related field, along with hands-on experience in developing key study documentation in compliance with regulations like IVDR or similar frameworks.

Natera fosters an inclusive environment that supports Principal Medical Writers through comprehensive training, access to industry resources, and collaboration with experts from various fields. You'll work alongside highly skilled professionals, allowing for mentorship opportunities and the sharing of knowledge, which is crucial for your professional growth and success in clinical documentation.

The salary range for a Principal Medical Writer at Natera is between $143,800 and $180,000 USD annually. Compensation packages can vary depending on several factors, including the candidate's experience, skill set, and office location. Natera also offers competitive employee benefits and various perks.

At Natera, the work environment is dynamic and collaborative, emphasizing teamwork and innovation. As a Principal Medical Writer, you'll engage with diverse teams across Medical Affairs, Regulatory Affairs, and Scientific Communications. This enriching atmosphere encourages professional development and allows you to effectively influence critical processes within clinical affairs.

In responding to this question, it's essential to discuss your hands-on experience with developing CPSPs, including specific examples where you've led or significantly contributed to their creation. Highlight your familiarity with regulatory requirements and illustrate how your contributions have impacted previous projects.

When answering, consider utilizing the STAR method (Situation, Task, Action, Result) to describe a relevant scenario where you successfully managed multiple projects simultaneously. Discuss your strategies for maintaining compliance and ensuring quality, such as effective communication and prioritization techniques.

Share your approach to collaboration, emphasizing communication and adaptability. Provide concrete examples of how you've worked with teams such as Medical Affairs or Regulatory Affairs, highlighting your ability to offer valuable input while fostering a cohesive working relationship.

Identify key documentation types relevant to regulatory submissions, such as CPSPs and Performance Study Reports. Explain why these documents are critical, what they should encompass, and how you ensure they meet regulatory guidelines in your writing.

Detail your methods for keeping informed about changes in relevant regulations, such as attending workshops, subscribing to industry newsletters, and engaging with professional organizations. Highlight your commitment to continuous learning and adapting your practices accordingly.

Comment on your systematic approach to clinical study design, explaining any frameworks or methodologies you follow. Discuss aspects such as study objectives, participant selection, and the importance of aligning study design with regulatory expectations.

Explain your quality assurance process, including peer reviews, adherence to guidelines, and how you incorporate feedback. Highlight your attention to detail and any tools or systems you utilize to maintain high standards.

Use the STAR method to articulate a specific challenging project, emphasizing not just the complexity but how you navigated obstacles to achieve the desired outcomes. Showcasing problem-solving skills here will be paramount.

Share examples that illustrate your experience collaborating with external partners, such as pharmaceutical sponsors or CROs. Focus on your role in ensuring that project deliverables are met and how you manage expectations and communications.

Discuss your aspirations for the role, aligning them with Natera's mission and vision. Be specific about the contributions you'd like to make, such as improving clinical documentation processes, leading innovative projects, or enhancing cross-functional collaboration.