Danaher Corporation Senior Medical Writer in Newcastle Upon Tyne, United Kingdom
Leica Biosystems associates know that every moment matters when it comes to cancer diagnostics. When we come to work, we’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people as a Senior Medical Writer and be inspired to grow every day. Learn more about Leica at www.leicabiosystems.com.
Position Summary and Overview
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 Medial 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:
Under minimal direction, the Senior Medical Writer independently critically 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.
Owns and coordinates the review process for study reports, manuscripts, and other written communications to differentiate LBS products in the market.
Utilizing knowledge of medical writing best practices, develops standard work for preparation and maintenance of compliant medical writing deliverables.
Acts as a resource for colleagues with less experience.
Your areas of knowledge and expertise that matter most for this role:
BS/BA and 6 years, MS/MA and 4 years, or PhD 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 with 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 organizational skills and ability to work on multiple projects simultaneously
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) .