Internship - Regulatory, Quality, Standards & Governance

Description du poste:

About This Role:
As a Regulatory, Quality, Standards & Governance Intern, you will be a vital part of the Regulatory, Quality, Standards & Governance team, contributing significantly towards ensuring smooth product registration and launch within the Polish affiliate. With guidance from your assigned mentor, you'll engage in supporting projects such as product information updates, artwork verifications, and presentation reviews. Your role is pivotal in maintaining compliance and assisting in daily operations like processing quality technical product complaints and managing serialization alerts. This position offers a unique opportunity to gain experience in varied aspects of regulatory affairs, quality assurance, and governance, crucial for advancing your career in the biotechnology sector.

What You'll Do:
* Assist in the development and maintenance of compliance documentation, including policies and SOPs.
* Review and translate English product information documents into Polish.
* Prepare documentation for submission to Polish Health Authorities.
* Collaborate with departments to communicate approvals and business process changes.
* Verify graphic designs of product leaflets and packages for compliance.
* Support the verification of promotional and scientific materials.
* Monitor regulatory competitive intelligence and legal acts.
* Archive regulatory department documentation.
* Prepare PowerPoint presentations for departmental use.
* Participate in department's ongoing projects.

Who You Are:
You are an enthusiastic individual ready to immerse yourself in the world of regulatory affairs. You have an eye for detail and precision, which ensures accuracy in your work. Your excellent communication and organizational skills allow you to effectively collaborate and build relationships within the team. You possess a flexible mindset and a high energy level, enabling you to handle stress and adapt to changing environments. Trustworthy and reliable, you set high ethical standards and resonate with our Biogen values.

Required Skills:
* Scientific or Medical Degree (MA, BA).
* Fluency in Polish and English.
* Excellent communication and teamwork skills.
* Strong organizational abilities and attention to detail.
* Ability to work independently with a proactive attitude.

Preferred Skills:
* Advanced terminal degree (MD, PhD, PharmD).
* Experience in handling customer relations and networking.

Additional information:
* This is a 12-month internship, up to 32 hours per week, with an hourly rate of 31,40 PLN.
* Candidates must based in Poland, have a valid work permit, and be fluent in Polish.

Job Level: Internship

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States