Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
Provide medical input to global clinical studies and advise teams and business partners, focusing on patients' safety and well-being.
Collaborate with internal departments in preparing clinical development plans, protocols, investigator brochures, and clinical study reports.
Review and analyze clinical data to ensure the safety of study participants and ensure data accuracy and trial compliance.
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. They're a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries, committed to delivering high-quality, timely services. PSI fosters an environment where a diverse range of colleagues feel welcomed and valued, enabling them to attract and retain top talent globally and build a community where every team member has the opportunity to thrive.
Provide first-line remote technical support for Growth Direct™ system robotic, software, imaging, and microbial related issues.
Manage customer complaints per SLAs, Escalation Processes, and with Technical Service Engineer coordination as needed.
Case management within the Customer Relation Database, inputting pertinent information that includes date stamps, symptoms, investigation details and the resolution.
Rapid Micro Biosystems creates innovative products for fast and accurate detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. They are headquartered in Lexington, Massachusetts with R&D and manufacturing operations in Lowell, Massachusetts and field offices in Germany, Switzerland, and Singapore.
Engage, educate, and support Galleri ordering providers and cancer diagnostic specialists, oncologists, Key Opinion Leaders (KOLs), and Health Care System (HCS) influencers.
Maintain in-depth clinical, scientific, and technical expertise related to GRAIL’s products, cancer screening, and cancer diagnostic guidelines.
Summarize and communicate complex medical messages to enable clear and concise understanding by both external audiences and partners within GRAIL.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are supported by leading global investors and pharmaceutical, technology, and healthcare companies.
Medical expert with specialized therapeutic expertise.
Maintain consultative relationship with clients.
Provide medical expertise / leadership in Proposal Development Teams.
Parexel improves world health. They provide biopharmaceutical services, helping clients transform scientific discoveries into new treatments, with values like Patients First, Quality, Respect, Empowerment & Accountability.
Working in a global team of data scientist who are subject matter experts in Data Analytics applications within Biopharma.
Assisting customers in solving business related problems using advanced data analytics.
Supporting implementation of advanced analytics in industry
Sartorius Data Analytics is a market leader in advanced analytics and provider of Umetrics Suite of Data Analytics Solutions. They are on a strong growth path driving new innovative solutions in the field, and their stock is listed on the German DAX and TecDAX.
Answers questions and assists clients with method and equipment selection.
Assists clients in understanding reported results and how they compare to Occupational Exposure Limits.
Acts as the client liaison to the laboratory to ensure all aspects of the project are carried out in the best interest of the client and the laboratory.
SGS is the world's leading Testing, Inspection and Certification company with over 145 years of service excellence.
Drive sales and customer success for Veeva LIMS to biotechnology companies.
Achieve team quarterly and annual sales goals.
Execute sales cycles, using internal and external resources.
Veeva Systems is dedicated to providing cloud solutions for the life sciences industry, helping companies bring therapies to patients faster. They are a fast-growing SaaS company with over $2B in revenue and are committed to balancing the interests of customers, employees, society, and investors.
Drive market share growth and lead robotic hybrid procedure introduction.
Enhance surgical expertise and support portfolio expansion through collaboration.
Guide surgical teams, influence market adoption, and execute market development programs.
Jobgether is a platform that uses AI to match candidates with jobs and ensure fair and objective reviews. They aim to quickly connect top candidates with hiring companies.
Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards.
Own the quality approval process for software components, including documentation review and final release approvals.
Partner with the software engineering team to implement and maintain a robust software quality management system.
Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.
Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.
This position is posted by Jobgether on behalf of a partner company.
Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
Performs and/or coordinates complaint investigations and gathering of additional information.
Ensures issues are being addressed and escalated in a timely manner.
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information.
Drive execution of NPI strategy to develop scalable, high-yield processes.
Optimize inspection strategies through technology, automation, and supplier certification.
Coach and develop a team of quality engineers to meet performance metrics.
Stryker is a leading medical technology company committed to improving healthcare. They offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine. They are proud to be named one of the World’s Best Workplaces!
The Medical Science Liaison / Senior Medical Science Liaison functions as a highly trained, field-based, scientific expert. They will facilitate and build scientific relationships and collaborations with the medical/scientific community. Provide educational, scientific, and research support for the SOBI rare disease portfolio of products in the hematology franchise.
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies.
Respond to customer inquiries and maintain records.
Monitor the status of biopharma commercial projects in real-time.
Develop a biopharma menu of services with accurate pricing to support customer quotes.
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA, providing precision at a scale that is otherwise unavailable to its customers. They serve people who are changing the world for the better in industries such as healthcare, agriculture, chemicals and data storage.
Provide oversight of assigned clients, including implementation and ongoing management. Understand client needs and ensure deliverables meet expectations and KPIs. Triage and respond to medical information inquiries from healthcare professionals, consumers, and payers.
EVERSANA is committed to creating and delivering next-generation commercialization services to the life sciences industry with over 7,000 employees.