Senior Specialist, Medical Writing

As a Senior Specialist in Medical Writing at Edwards, you're responsible for authoring and providing scientific expertise throughout the development of clinical evaluations and post-market clinical follow-up documents. You'll act as the primary contact for medical writing projects, negotiate timelines, and ensure compliance with regulatory standards. Collaborating with cross-functional teams, you will provide complex medical writing deliverables that significantly impact patient care.

To qualify for the Senior Specialist Medical Writing position at Edwards, candidates should hold either a Bachelor's Degree with five years of related experience or a Master's Degree with three years of experience in medical writing. A deep understanding of MEDDEV 2.7/1 and EU MDR guidelines is highly preferred, along with strong communication and leadership skills to navigate complex projects efficiently.

In the role of Senior Specialist in Medical Writing at Edwards, your contributions are vital to enhancing patient care. By ensuring the accuracy and clarity of clinical evaluation documents and post-market studies, you help regulatory bodies understand the safety and efficacy of our medical devices, ultimately supporting their successful adoption in clinical settings to improve patient outcomes.

In the Senior Specialist Medical Writing role at Edwards, soft skills such as exceptional written and verbal communication, problem-solving abilities, and critical thinking are crucial. Additionally, your ability to influence and lead cross-functional teams while maintaining strong relationships with stakeholders will help drive projects to successful completion and enhance collaboration within the organization.

The work environment for a Senior Specialist in Medical Writing at Edwards is dynamic and collaborative. You’ll be part of a team that values innovation and excellence, where your insights and expertise will help shape the regulatory landscape of medical devices. The culture encourages professional growth and teamwork, ensuring that all employees are aligned with the mission of improving patient lives.

In discussing your experience in medical writing, focus on specific projects or documents you've authored that are relevant to the medical device industry. Highlight your familiarity with regulatory requirements and your ability to convey complex scientific information clearly and concisely, which are essential skills for the Senior Specialist role at Edwards.

To effectively manage competing priorities, share your organizational strategies, such as using project management tools or prioritizing tasks based on deadlines and impact on overall goals. Emphasize your adaptability and ability to maintain quality while meeting tight timelines, which is critical for a Senior Specialist in Medical Writing at Edwards.

When addressing the challenges of medical writing, discuss aspects like the need for meticulous attention to detail, staying updated with regulatory changes, or managing feedback from various stakeholders. Illustrate how you tackle these challenges with proactive planning and collaboration with your team at Edwards to ensure high-quality deliverables.

Reflect on a specific instance where you successfully negotiated timelines or deliverables with a project team. Highlight how you communicated openly with stakeholders to understand their perspectives and arrive at a mutually agreeable solution, showcasing your negotiation skills and commitment to collaboration as a Senior Specialist at Edwards.

Discuss your thorough review processes, including peer reviews, adherence to regulatory standards, and utilizing established templates and guidelines. Mention specific examples of tools or checklists you use to maintain compliance and ensure precision in all documents you produce as a Senior Specialist in Medical Writing.

Explain how literature reviews inform your writing by providing context, supporting data, and ensuring that your work aligns with current research. Emphasize your experience in conducting effective literature searches and synthesizing findings to enhance the quality and credibility of the documents you write for Edwards.

Share an instance where you provided guidance to a junior medical writer. Discuss how you offered specific feedback on their work, shared best practices in writing and document preparation, and fostered their professional development through regular check-ins and knowledge sharing.

Mention ways you actively engage with professional organizations, attend workshops, or participate in webinars that focus on regulatory updates. Being proactive about learning will demonstrate your commitment to maintaining high standards in your medical writing role at Edwards.

Discuss your strategy for identifying areas for improvement, such as gathering feedback from team members or analyzing past projects. Showcase your experience in implementing process improvements that have enhanced efficiency and quality in medical writing, reflecting a solution-oriented mindset.

Articulate your passion for contributing to innovative healthcare solutions and how Edwards aligns with your career goals and values. Emphasize your commitment to making a meaningful impact in patients' lives through your medical writing expertise and your enthusiasm for collaborating with a dedicated team.