Johnson & Johnson este o companie globală din domeniul sănătății, care activează în medicina inovatoare și tehnologia medicală. Echipele sale dezvoltă soluții în oncologie, imunologie, neuroștiință, oftalmologie de specialitate, îngrijire intervențională și ortopedie, combinând știința și tehnologia pentru a răspunde unor nevoi complexe de sănătate. Compania pune, de asemenea, accent pe echitatea în sănătate, sustenabilitatea mediului, diversitate și incluziune, deservind furnizori de servicii medicale, pacienți și comunități din întreaga lume.
Staff Scientist, Clinical Development Research – Raynham, MA (Hybrid)
Lead clinical evidence strategy and development programs for Johnson & Johnson’s Orthopaedics portfolio. Guide regulatory submissions, evidence communication, and lifecycle management initiatives for new products.
Descriere
- Lead global evidence-generation and dissemination strategies for assigned new product development and lifecycle management projects
- Coordinate strategy with regional medical device Clinical R&D leaders and priority countries or regions
- Prepare clinical trial protocols, informed consent forms, investigator brochures, and related study documentation
- Develop study budgets and coordinate investigator, site, vendor, payment, and financial disclosure activities with Clinical Operations
- Execute clinical programs with Clinical Operations, Biostatistics, and Data Management teams on schedule, within budget, and in accordance with regulations and SOPs
- Maintain productive relationships with study core teams and escalate study issues to leadership
- Prepare annual reports, study closeout reports, and clinical sections for IDE, PMA, 510(k), and other regulatory submissions
- Evaluate scientific literature and prepare Clinical Evaluation Reports
- Contribute to clinical science discussions with regulatory agencies and notified bodies
- Analyze and communicate evidence through abstracts, manuscripts, clinical study reports, market access, and reimbursement activities
- Develop and maintain relationships with key investigators
- Manage clinicaltrials.gov registration from study launch through results submission
- Build knowledge of the pipeline, product portfolio, and business priorities
- Keep management updated on issues and developments affecting clinical strategy and portfolio management
- Escalate relevant business issues and opportunities to the next level of management
- Maintain compliance with applicable regulations, company policies, and procedures
- Complete additional clinical research responsibilities as assigned
Cerințe
- Bachelor’s degree or equivalent in biological science or a related field
- At least six years of relevant scientific, technical, or clinical research experience
- Experience with or knowledge of biomaterials and/or spine is preferred
- Knowledge of Good Clinical Practice
- Knowledge and practical application of clinical regulations and standards across applicable regions
- Strong presentation skills with the ability to influence effectively
- Clear written and verbal communication skills
- Ability to lead with professionalism and integrity
- Technical writing proficiency
- Knowledge of clinical research science and processes
- Understanding of product development, team dynamics, healthcare markets, clinical trends, and global clinical trial regulations
- Ability to provide strategic clinical research guidance across new product development and lifecycle management projects
- Demonstrated success delivering clinical projects in clinical or surgical research settings on schedule, within budget, and in compliance with SOPs and regulations
- Ability to lead study teams and achieve critical milestones
- Ability to work across functions and support business objectives
- Ability to build productive partnerships with internal and external stakeholders
- Ability to influence, shape direction, and lead without direct reporting authority
- Compliance with applicable laws, policies, regulations, procedures, and the company compliance program
Beneficii
- 120 hours of vacation per calendar year
- 40 hours of sick time per calendar year, or 48 hours in Colorado and 56 hours in Washington
- 13 calendar days of holiday pay, including floating holidays
- Up to 40 hours of work, personal, and family time per calendar year
- 480 hours of parental leave within one year of a child’s birth, adoption, or foster placement
- 240 hours of bereavement leave for an immediate family member and 40 hours for an extended family member per calendar year
- 80 hours of caregiver leave during a rolling 52-week period
- 32 hours of volunteer leave per calendar year
- 80 hours of military spouse time off per calendar year
- Employee benefits information is available at careers.jnj.com/employee-benefits