Medical Affairs Director La South
hace 4 semanas
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
Medical Affairs & Regulatory Director LA SouthPurpose : Directs the operational function in medical affairs, regulatory and pharmacovigilance to achieve organizational objectives. Responsible for the design, development and implementation of programs related to educational, promotional and reporting materials for products related to Phase IIIb, Phase IV trials, solicited and non-solicited studies, publications, regulatory strategy, pharmacovigilance requisites.
You will be responsible for :
- Directs the operational function in medical affairs, regulatory and pharmacovigilance. Oversees the design and implementation plans of medical affairs program. Ensures medical affair's objectives are aligned with the goals and mission of the company.
- Reviews and approves educational, promotional and reporting materials for use by internal stakeholders.
- Directs budget management, contract negotiation and oversight of vendor activities.
- Strategizes and prioritizes publication proposals, design and implement regulatory strategy. Serve as the project champion to insure timeline adherence and project completion.
- Develops and provides input to research protocols for specific projects promoting company message and value.
- Directs implements plans for clinical trials, including protocol, staffing, and budgeting as it relates to strategic initiatives (IIS).
- Develops policies and procedures for development. Partner with GCO/MAO top foster clinical investigation efforts in the country.
- Executes plans for continuous improvement to create an environment in Medical Affairs, Regulatory and Pharmacovigilance that encourages and recognizes creativity, innovation, teamwork, risk taking and empowerment that fosters new product development.
- Implements the company's drug surveillance/product safety program which includes following up on adverse reaction reports. Provides solutions surrounding legal liability and compliance with government.
- Ensures collaborative working relationship between Medical Affairs and internal stakeholders to deliver timely and expert support to product development.
Qualifications :
- MD, Doctor of Medicine
- 10 - 12-year solid experience in Medical Affairs, Regulatory, and Pharmacovigilance areas in the Pharm Industry
- Strong experience leading strategic and field teams both face to face and remotely.
- Orientation to results, strive for excellence in execution.
- Sense of urgency
- Strong analytical skills
- Fluent communication and presentation skills
- Travel: 25%
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