Danaher Corporation Medical Writer in New York, New York
Nearly every one of us has been impacted by cancer in some way. When you join Leica Biosystems, you’re helping make a difference in advancing cancer diagnostics. Join our global team as a Medical Writer and help us transform the industry!
The Clinical & Medical Affairs function provides leadership and direction on medical, scientific, and clinical decisions related to the overall Leica Biosystems business strategy. The scope of the Medical Writer role involves working with cross-functional teams to prepare high-quality publications, regulatory documents, performance reports, literature searches, research protocols, and related documents.
Responsibilities we will trust you with:
Collaborates with Clinical Affairs and relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing) to aid in design and preparation of clinical and analytical performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
The Medical Writer evaluates, analyzes, and interprets the medical literature to select primary resource materials for adequate study design, medical evidence, statistical significance, scientific difficulty, and absence of bias.
Utilizes professional judgment and creative expertise to integrate the pertinent clinical data into an original summary document that is clear, accurate, concise, comprehensive, and devoid of promotional overtone. Assumes responsibility for ensuring that the finished document is complete, accurate and follows approved format.
Develops and maintains ongoing relationships with Regulatory Affairs, Clinical Affairs, and Product Marketing teams, and understands how Medical Affairs integrates with these departments.
Conducts in-depth literature searches following established operating company procedures.
Authors study reports, manuscripts, and other written communications to differentiate LBS products in the market.
Utilizing knowledge of medical writing best practices, assists in development of standard work for preparation and maintenance of compliant medical writing deliverables.
Your areas of knowledge and expertise that matter most for this role:
BS/BA and 4 years, MS/MA and 2 years in related medical writing experience, preferably in in vitro diagnostic or medical device industry
American Medical Writing Association (AMWA) certification or other is helpful
Experience of critically analyzing clinical articles, datasets, and reports in terms of clinical performance
Experience writing IVDR Clinical Performance Reports, Literature Search Reports, and Scientific Validity Reports is highly desirable
Excellent communication skills, both verbal and written
Excellent organizational skills and ability to work on multiple projects simultaneously
- Travel expectations for this role are Low (<10%)
US Remote, preferably near Leica Biosystems office
What we have to offer:
Check out our benefits here: https://danaherbenefitsinfo.com/
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .