Senior Director, Global Head Nonclinical
il y a 4 jours
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.
Who is Janssen?
We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives.
Our Mission and Vision:
Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate, but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
The Senior Director has a desire for mentoring, learning, innovation and continued career development through participation in and presentations at regulatory meetings and/or scientific meetings in pharmaceutical industry.
A combination with a project leadership role in PSTS for compounds in development is an option.
**Major Duties & Responsibilities**:
- Responsible for documents required for global regulatory interactions being delivered with high quality, consistency and maximal efficiency. Ensures clarity of communication of cohesive stories in those documents
- Assures close collaboration with relevant functions, in particular with nonclinical project leaders and therapeutic area leaders, PSTS functional area leaders, as well as other relevant roles in Janssen R&D departments involved in regulatory submissions.
- Strong understanding of the regulatory landscape and processes in pharmaceutical organizations to facilitate collaborative partnerships. Engages external network to advise submission strategies. Ensures compliance with global regulations.
- People leader role for a global organization of scientific nonclinical writers and document specialists, including hiring, leading and developing staff, succession planning, efficient and global resourcing, as well as mentoring of relevant PSTS personnel in growing writing skills and soft skills.
- Identifies and timely addresses potential hurdles that may impact business conduct and ensures processes are globally aligned to provide results in an efficient way and with high quality.
- May serve in a project leadership role in PSTS
**Qualifications**
- Master’s degree in medical sciences / life sciences with at least 15 years of experience in the pharmaceutical industry, specifically in scientific writing and/or project management, preferably in the Nonclinical Safety arena. Ph.D. degree preferred
- Confirmed track-record in and passionate about leading teams, including direct people management in a global setting.
- Experience with verbal and non-verbal interactions with regulatory authorities and excellent knowledge of the regulatory landscape. Shown excellence in scientific writing skills
- Exceptional diplomacy and communication skills
- Clear attention for detail, preferably experience with Good Laboratory Practices
- Strong ability to work optimally in a collaborative and global environment
- Located in one of the following areas: Beerse, BE, Spring House, PA, Raritan, NJ, La Jolla, CA
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
**Primary Location**
United States-Pennsylvania-Spring House-Welsh & McKean Roads
**Other Locations**
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan, North America-United States-California-La Jolla
**Organization**
Janssen Research & Development, LLC (6084)
**Job Function**
R&D
**Requisition ID**
2206057560W
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