In Bayer”s Pharmaceuticals division, we focus on researching, developing and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.
The regulatory affairs organization at Bayer plays an important role in advancing Bayer”s discovery and development of innovative medical products by working with internal stakeholders and global regulatory agencies to bring these products to patients. With the approval of numerous drugs in a variety of indications throughout the world, Bayer has an expertise in drug development. Currently Bayer operates in over 80 countries where regulatory teams work with numerous agencies to bring novel products to patients around the world. With Bayer”s global footprint and diverse portfolio of medical products across a range of therapeutic areas, Bayer”s regulatory affairs organization is well positioned to continue delivering innovative medical products to address unmet global medical needs. We are looking for strategic thinkers and effective communicators who want to have an impact in a fast paced, global drug development environment to bring novel medicines to people who need them.
An objective of this internship/co-op program is to provide experiential learning opportunities in global regulatory affairs to facilitate an understanding of the regulatory framework for global drug development and exposure to the development of innovative oncology therapies. By working alongside Bayer regulatory experts, you will receive extensive mentorship and training. In addition you can expect to gain valuable knowledge of regulatory affairs and develop important skills that are relevant for future strategic roles in regulatory affairs or other related disciplines in drug development. This experience will also enable you to build a professional network in regulatory affairs and drug development to support career development. In this global regulatory affairs internship/co-op program you will have the opportunity to work directly with global regulatory strategists and as part of a global regulatory team that is actively contributing to the progression of pipeline products towards key development milestones.
You will learn about FDA/global regulations for investigational new drugs and the requirements that must be fulfilled to enable initiation and conduct of human clinical trials with a novel oncology therapy. You will also be exposed to later stages of drug development which may include learning about the development and regulatory process for the approval of novel claims for previously approved products. Importantly you will have the opportunity to contribute to the formulation of regulatory strategies to support innovative therapies at different stages of development by conducting research, precedent analyses and
monitoring of the regulatory environment and applying insights to assigned projects.
The primary responsibilities of this role, Global Regulatory Affairs Oncology Intern, are to:
- Work directly with global regulatory strategists and as part of a global regulatory team that is actively contributing to the progression of pipeline products towards key development milestones;
- Learn about FDA/global regulations for investigational new drugs and the requirements that must be fulfilled to enable initiation and conduct of human clinical trials with a novel oncology therapy;
- Be exposed to later stages of drug development which may include learning about the development and regulatory process for the approval of novel claims for previously approved products;
- Contribute to the formulation of regulatory strategies to support innovative therapies at different stages of development by conducting research, precedent analyses and monitoring of the regulatory environment and applying insights to assigned projects;
- Be expected to prepare and make a presentation on a regulatory topic of mutual interest thereby sharing acquired knowledge with the Bayer regulatory community.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Currently enrolled in a Master”s, PharmD, Ph.D., M.D. or postgraduate fellowship program with a focus in the life sciences (i.e. Biology, Chemistry, Regulatory Affairs etc.;
- High performance with strong work ethic;
- An interest in learning about global regulatory affairs and drug development;
- Ability to work collaboratively in a team setting;
- Ability to communicate effectively, both verbally and in writing;
- Excellent attention to detail.
- Available to work during one of the following three timeframes :
- January 2021 – June 2021 (6 months);
- May 2021 – August 2021 (3 months);
- June 2021 – September 2021 (3 months).
Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the “Passion to Innovate” and the “Power to Change”, we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.