Location: Spring
Company: Johnson & Johnson
Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension.
Visit us: Janssen Research & Development, L. L. C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease,
diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Lead Regulatory Scientist provides support for regulatory activities for products in the assigned portfolio, including ensuring that content and intent of regulatory filings support the global regulatory strategy.
Key Responsibilities: Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area Assist in the preparation of meetings and act as backup for contact with
Regulatory Agencies as needed Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy Work cross-functionally and lead team meetings as appropriate Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements Advise team in required documents and submission strategies Support the development and improvement of processes related to regulatory submissions Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas Interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact May have interaction with internal and external colleagues with coordination between departments May represent J&J or company externally with some degree of supervision Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, practices and approaches Qualifications Education: One of the following combinations of education and experience is required: A Bachelor's Degree with a minimum of 6 years of relevant experience An Advanced/Master's Degree with a minimum of 4 years of relevant experience A Pharm D/Ph D with a minimum 2 years of relevant experience Experience and Skills: Required: Previous health regulatory industry experience and understanding of the drug development process is required Skilled at effectively prioritizing assignments for multiple projects simultaneously is required Experience within a cross-functional team environment as an individual contributor and decision maker within a matrix organization is required Strong interpersonal and communication skills is required Preferred: Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines is preferred Relevant regulatory affairs experience in medical/biotech is preferred Experience responding to Healthy Authority (HA) requests, managing HA interactions and life cycle management of IND/CTA/NDA/MAA applications is preferred Project management experience and ability to manage multiple priorities is preferred Diverse therapeutic area experience is preferred Direct experience in regulatory affairs is preferred Regulatory, Clinical or R&D experience with products in early and late development stages is preferred Experience responding to FDA requests, leading FDA interactions, and lifecycle management of IND/NDA applications is preferred Immunology Drug Development experience is preferred Other: 10% domestic travel and potential international travel may be required for this position Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.
trainees. JOB REQUIREMENTSMinimum Education BS in shop or Pharm D. Minimum Work Experience No previous experience Required Licenses/Certifications Active License as registered pharmacist in the state of Texas Required Skills, Knowledge, and Abilities Ability to effectively direct and/or supervise personnel as appropriate.
Ability to handle confidential information. Ability to maintain professional appearance and decorum at all times. Ability to demonstrate excellent oral and written communication skills. Location: Hendrick Health · PHM shop - Main Schedule: Full Time, Varied Shifts, 3 weekdays and every other weekend For more details: jobs-search. org/pharmacist-i_abilene-c448636/pharmacist-i-north-abilene_i1966534049
that supports learning, mentoring, and building every team member. n n Medical Oncology n Patient Population: Med/Surg Oncology, Chemo, Overflow PCU/SDU, Postop Bladder Surgery, Postop Colon Surgery, Palliative Care, End of Life and Hospice Support n Patient Ratios: 1:4 for PCU and Chemo; 1:5 for Med/Tele n Number of Beds: 20 beds n Department Specifics: Active Unit Based Council, Pharmacist and Social Worker on the unit during the day to partner with nurses in patient care, Multidisciplinary Team that works together, Chemotherapy training is available after 6 months, Unit Specific Oncology Education Program, We love celebrating together in an environment that encourages excellence.
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Shift: Full Time Days; 7am-7pm n n Why Baylor Scott & White Medical Center– Grapevine n For nearly 70 years, Baylor Scott & White Medical Center – Grapevine has provided personalized, compassionate, and loving care to more than 20 communities in the Dallas Fort Worth region.
It has steadily expanded its capabilities, and now provides more comprehensive services to those with complex conditions closer to their home. n A Magnet Recognized Facility, Baylor Scott & White Medical Center – Grapevine is a 302-bed hospital offering advanced medical services for heart and vascular, women’s health, diagnostic imaging, trauma, orthopedics, spine, digestive diseases, oncology, neurology, ENT, pain
management, weight loss and intensive and emergency care. n Baylor Scott & White Medical Center– Grapevine has a Level III Neonatal Intensive Care Unit and is the only Level II Trauma Center in Northeast Tarrant County.
Additionally, the facility is an accredited Cycle IV Chest Pain Center, Primary Stroke Center and accredited in weight loss surgery, oncology, etc. The hospital was recognized by U. S. News & World Report in its 2021-2022 “Best Hospitals” ratings as high performing in the common procedures and conditions category for stroke, heart failure, kidney failure and COPD (chronic obstructive pulmonary disease). It was also recognized by U. S. News & World Report as the only Tarrant County hospital, and one of only two hospitals in the Dallas Fort Worth region, rated High Performing, the highest-possible rating for Best Hospitals for Maternity for 2021-2022.
Built on a legacy of care, Baylor Scott & White Medical Center – Grapevine is focused on caring for and loving patients in a safe and healing environment. n n We welcome applicants who will serve faithfully, act honestly, never settle, and recognize that we are in it together to deliver world-class healthcare. n n Why Baylor Scott & White Health n n At Baylor Scott & White Health, we empower each other to create healthier communities and deliver safe and high-quality care across the state of Texas.
With more than 52 hospitals, 800 access points, a quality health plan and an award-winning research institute, you’ll enjoy endless opportunities to make your mark on the future of healthcare. At Baylor Scott and White Health, you’ll be joining a team that’s committed to better. Because better never settles. And neither should you. n n As the largest not-for-profit healthcare system in Texas and one of the largest in the United States, Baylor Scott & White Health has the resources to offer a variety of career opportunities to meet your personal and professional goals.
n n The Baylor Scott & White Health nursing team challenges each other to innovate, to constantly raise the bar and to never settle. Every day, our diverse group of team members bring unique talents, a passion for innovation and a deep Commitment to those we serve. n n Baylor Scott & White Health Registered Nurses Enjoy n n· Competitive pay including an RN Bonus Program rewarding nurses for providing exceptional care and improving patient outcomes. n· Attractive Relocation Assistance for full-time candidates.
n· Excellent benefits including a generous 401(k) program with company match, vacation and paid time off (PTO), tuition assistance, immediate eligibility for health and welfare benefits and wellness programs to keep you and your family healthy. (Note: benefits may vary based on position type and/or level). n· A strong shared governance model featuring unit-based councils that empower nurses and improve patient outcomes. nn Access to more than 4,000 hours of online continuing education for professional development. n A strong system Nurse Practice Council that uses autonomy, authority and accountability in collaboration with transformational nursing leadership to drive nursing practice throughout Baylor Scott & White Health.
n A spirit of inquiry and innovation that promotes Evidence-based practice, research and innovations in nursing practice. nn· A healthy work environment and culture of safety using inter-professional collaboration and professional competencies to meet the needs of patients to provide safe passage and quality outcomes at every encounter. n n Baylor Scott & White Health is the most awarded system in Texas, and a Certified Great Place to Work! Consider a career move to Baylor Scott and White Medical Center - Grapevine and join our exceptional nursing team committed to something better.
QUALIFICATIONSnn EDUCATION - Grad of an Accredited Programn MAJOR - Nursingn CERTIFICATION/LICENSE/REGISTRATION - Registered Nurse (RN)n Basic Life Support (BLS): BLS or BLS within 30 days of hire or transfer. n For more details: jobs-search. org/sciences_grapevine-c448600/rn-med-oncology-grapevine_i1948888343
