About the Role
Title: Sr. Medical Writer, Clinical Affairs
Location: Remote – United States
Full time
job requisition id: 39762-JOB
Job Description:
What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Summary
Are you passionate about collaborating with cross-functional teams to create high-quality clinical study protocols and reports? If so, this opportunity is one you don’t want to miss.
We are looking for a Sr. Medical Writer to work on clinical protocols and reports for IVD/device product development. In this role, you will have the chance to work on innovative NGS clinical products that could significantly influence modern diagnostics and improve patient care.
Responsibilities
- Work with R&D scientists, clinical affairs, regulatory affairs, and medical affairs teams to plan, write, and edit IVD/medical device study protocols and reports for registrational or non-registrational purposes.
- Work efficiently and accurately, adhering to best practices and departmental standards for terminology, content management, and reuse.
- Release finished documentation to Document Control, and maintain organized records of all materials, drafts, and previous versions.
- Quickly learn and apply new tools, processes, and standards as needed.
- Be adaptable and forward-thinking in the face of technological or organizational change.
- Propose improvements to authoring tools and work closely with study leads to evaluate and implement. Initiate and drive projects to improve efficiency and sensible cost avoidance
Requirements & Education
- Ph.D. or M.S. in life sciences with experience in protocol development, data analysis, and report writing for IVD/medical device analytical and clinical performance studies.
- Knowledge and familiarity with genomic NGS data.
- Broad experience in study design and data analysis for IVD/medical devices is required, and experience with industry publications is a plus.
- Excellent and proven team skills, written and oral communication skills.
- Be a strong partner who intelligently gathers input from multiple stakeholders and deals effectively with ambiguous or missing information.
- The job requires strong organizational skills and excellent time and project management and must thrive in a fast-paced environment.
- Influencing across boundaries, finding win-win solutions, and responding to obstacles creatively and resourcefully are key characteristics.
- A sophisticated understanding of the principles and practices of medical writing, content management, and reuse is essential.
- Expert in Microsoft Office, Adobe Acrobat, and web authoring tools.
- Proficient in English with excellent grammatical and editorial skills, and attentive to industry-leading writing standards.
- Listed responsibilities are an essential, but not an exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.