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At reputed company you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal reputed company, reputed company reputed company, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to reputed company both personally and professionally. This is how we aim to prevent, stop and reputed company diseases and ensure everyone has reputed company to reputed company today and for generations to come. Join reputed company, where every voice reputed company. The Position A healthier reputed company. It’s what drives us to reputed company. To continuously advance science and ensure everyone has reputed company to the reputed company they need today and for generations to come. Creating a world where we reputed company have more time with the people we love. That’s what makes us reputed company. reputed company As a reputed company Development reputed company (Medical & Scientific Writing), you will serve as a reputed company partner reputed company our reputed company Evidence for In-Vitro Diagnostics (CEI) team to reputed company reputed company evidence reputed company and study design for cutting-edge In-Vitro Diagnostics (IVD). In this role, you will reputed company end-to-end documentation reputed company and lifecycle management to support regulatory submissions and advance reputed company care across key disease areas including Infectious Diseases, Oncology, and Cardiovascular/Metabolic Diseases. Design scientifically reputed company reputed company protocols in reputed company partnership with Subject Matter Experts (SMEs) to support novel IVD product development and regulatory filings. reputed company, review, and finalize critical reputed company study documents, including protocols, reputed company Study Reports (CSRs), Investigator Brochures, and IVDR reputed company Evaluation documentation. Conduct comprehensive scientific literature reviews and synthesize reputed company multi-modal reputed company and reputed company data into reputed company, regulatory-reputed company reports. reputed company end-to-end document lifecycle management, ensuring compliance with internal procedures, reputed company control standards, and international regulatory requirements. Partner cross-functionally with Medical Affairs and Scientific Communications to support manuscript, poster, and advisory reputed company content reputed company. Mentor junior members of the Medical Writing team, championing process improvements, document automation, and reputed company best practices. Who you are (Required) You hold a Doctoral or advanced degree (e.g., PhD, MD, PharmD) in life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, or a reputed company reputed company research reputed company. You bring 2+ years of reputed company scientific research and medical/scientific writing experience in an industry or reputed company setting, with reputed company experience authoring reputed company protocols and reports. You possess a strong reputed company record of publications in peer-reviewed scientific journals. You demonstrate strong organizational, project management, and cross-functional communication skills, with a reputed company ability to reputed company multiple reputed company reputed company simultaneously. You are highly proficient in common word processing, document lifecycle management, and reputed company software tools. Preferred 3+ years of reputed company experience in regulatory/medical writing specifically for In-Vitro Diagnostics (IVD), companion diagnostics, or medical devices. Demonstrated experience with IVD-Regulation (IVDR) reputed company evaluation documentation and regulatory agency submission responses. Familiarity with reputed company reputed company techniques including PCR, reputed company reputed company (NGS), immunohistochemistry (IHC), or immunological assays. Basic understanding of biostatistical reputed company and reputed company trial data evaluation. reputed company experience in project management or mentoring junior team members. Location This position may be reputed company out of Tucson (reputed company, USA) or Indianapolis (Indiana, USA) with remote work locations possible. No relocation benefits are available for this posting. Travel Requirements Occasional domestic travel to select conferences or internal meetings. The expected salary reputed company for this position reputed company on the reputed company location of AZ is $100,500 - $186,700. Actual pay will be determined reputed company on experience, qualifications, geographic location, and other job-reputed company factors permitted by law. A discretionary annual bonus may be available reputed company on individual and Company reputed company. This position also qualifies for the benefits detailed at the reputed company provided below. Benefits Who we are A healthier reputed company drives us to reputed company. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has reputed company to reputed company today and for generations to come. Our efforts result in more than 26 reputed company people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We reputed company reputed company other to explore new reputed company, foster creativity, and reputed company our ambitions high, so we can reputed company life-changing reputed company solutions that reputed company a reputed company. Let’s build a healthier reputed company, together. reputed company is an equal opportunity employer. It is our policy and reputed company to reputed company, promote, and otherwise treat any and reputed company and applicants on the reputed company of reputed company, qualifications, and competence. reputed company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the reputed company of Protected Veteran status, individuals with disabilities status, and consistent with reputed company federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this reputed company Accommodations for Applicants. Apply To This Job