Sr. Medical Writer, Clinical Affairs

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.

#LI-REMOTE

The estimated base salary range for the Sr. Medical Writer, Clinical Affairs role based in the United States of America is: $96,500 - $144,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.