Support an in-house Medical Science team with Clinical Evaluation Reports (CERs) under the EU Medical Device Regulation (MDR) for CE Mark submissions, recertifications, labeling changes and ongoing EU conformance.
Locations (2)
California, United States
United States
Compensation
Up to $61/hr in California; up to $52/hr elsewhere in the U.S.
Responsibilities
Author sections of Clinical Evaluation Reports
Run or support comprehensive literature searches with the clinical librarian
Review and critically appraise scientific literature; write clinical summaries for products and procedures
Meet CER timelines and provide data to support global regulatory activities
Proofread, edit, format and integrate review comments through approval
Requirements
MD
PhD
MS in a scientific field
Nice to have: CER writing in the medical device industry
Lead an experimental research project while working with a cross functional team in the Frisco, TX Research & Development facility.
Compensation
$31.00/hour
Paid bi-weekly
$2,500 Sign-on Bonus, paid within 30 days of employment
Responsibilities
Conduct bench-top experiments, formula calculations, and develop prototypes
Maintain accurate and detailed record of laboratory work
Interpret test results, write technical reports and effectively communicate information within the organization
Use Excel & formulation software to document lab work and formulas
Work effectively with various functions of R&D (Sensory, Ingredients, Nutrition, Regulatory, Flavor Technology, Chemistry, Process Engineering, and Technical Services)
Requirements
Bachelor's degree in Food Science, Chemical Engineering, or related field
Support a dynamic portfolio of federally funded and investigator-initiated implementation science research within the Hansoti Research Group, coordinating complex studies from protocol development through dissemination.
The Sr. Research Project Manager helps build and lead the Design Nucleus at the Johns Hopkins School of Nursing, the School’s hub for advancing an ambitious agenda at the intersection of design and nursing. The role operates as both a strategic thought partner and an operational leader.
A senior scientific leader within the Cell Therapy Patient Safety Unit leading safety science strategy and delivery for complex cell therapy assets, integrating clinical, nonclinical, epidemiologic, and real-world evidence to shape safety profiles.
Compensation
The annual base pay for this position ranges from $203K to $305K.
Responsibilities
Lead safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets
Set the safety science strategy for multiple, complex or high-priority assets and translate emerging data into clear recommendations
Lead proactive pharmacovigilance and risk-management planning, including Global Risk Management Plans, REMS, risk-minimization measures and benefit-risk assessments
Provide strategic leadership and oversight for aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, and REMS
Lead safety content and strategy for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, and core data sheets
Requirements
Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
Advanced degree (MSc, PhD, PharmD) preferred in immunology, autoimmune disease, pharmacology, epidemiology or a related discipline
The Contractor of Scientific Communications will be responsible for the development and execution of the scientific communications strategy across the portfolio, leading day-to-day publication planning, congress activities, and scientific content development.
Compensation
$80 - $130/hour. The hourly salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
Responsibilities
Support development and lead tactical execution of the Publication and Medical Education plans in alignment with asset strategy and medical affairs objectives
Accountable for actively executing publication planning and publication development
Manage global publication activities (author engagement, abstracts, manuscripts, posters, oral presentations) in compliance with GPP and company SOPs
Serve as the scientific lead and scientific reviewer for publication deliverables, proactively identifying data gaps, inconsistencies, and interpretation risks and driving resolution with cross-functional SMEs
Oversee the execution of plans and activities for major international and regional medical meetings, including content development and internal alignment
Requirements
Advanced medical or scientific degree (MD, PharmD, PhD, MS, MPH)
An accomplished clinical educator, scholar, and academic leader to serve as Associate Director of Clinical Education and Training for the newly established McLean Center for Metabolic Psychiatry.
Compensation
The salary range for this position is $208,000 to $312,000 annually.
Responsibilities
Lead the development, writing, and dissemination of evidence-informed clinical guidelines and treatment protocols for metabolic psychiatry and integrated mental and metabolic healthcare.
Organize and lead multidisciplinary expert working groups involving psychiatry, psychology, nursing, social work, dietetics, health coaching, and other relevant disciplines.
Oversee literature reviews, critical appraisal of scientific evidence, and the synthesis of research findings into practical clinical recommendations.
Serve as a lead writer and editor of clinical guidelines, consensus documents, treatment protocols, and related scholarly publications.
Coordinate contributions from multiple authors and subject-matter experts, establish timelines, manage revisions, and ensure timely completion of high-quality written products.
Coordinates the day-to-day implementation of a large, federally-funded multi-state, community-engaged project in the Vanden Brink Research Lab, spanning research, education, and extension/outreach initiatives.
Compensation
Proposed Minimum Salary Commensurate
Responsibilities
Coordinates implementation and logistics for multiple research and outreach activities.
Provides administrative, operational, and project management support including managing complex calendars and coordinating meetings and travel.
Facilitates and coordinates site authorization for research community-based activities.
Supports the coordination of research visits and recruitment community events.
Maintains the project workplan and timelines, tracks progress, and flags delays.
Sr. Research Project Coordinator IINewJohns Hopkins University · Baltimore, US