Internship - Regulatory, Quality, Standards & Governance
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.
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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.
About Biogen Poland:
Nasza misja jest jasna: jesteśmy pionierami w dziedzinie neuronauki.
Od czasów założenia Biogen w 1978 roku przez Charlesa Weissmanna, Heinza Schallera, Kennetha Murraya oraz dwóch noblistów - Waltera Gilberta i Phillipa Sharpa jesteśmy jedną z pierwszych globalnych firm biotechnologicznych, która prowadzi wiodące badania naukowe. Szczególnie w ostatniej dekadzie, firma za cel postawiła sobie walkę z wyniszczającymi chorobami neurologicznymi.
Miliony ludzi na całym świecie żyją ze stwardnieniem rozsianym, chorobą Alzheimera, chorobą Parkinsona i stwardnieniem zanikowym bocznym (ALS). Wielu cierpi na choroby rzadkie, takie jak rdzeniowy zanik mięśni (SMA) czy postępujące porażenie nadjądrowe (PSP).
Jesteśmy przekonani, że żadna inna dziedzina nie kryje tak wielu obietnic i tak ogromnych nadziei na przełomowe odkrycia, jak neuronauka."
Biogen zatrudnia jednych z najlepszych na świecie neurologów i ekspertów z dziedziny neuronauki. Nasza współpraca z lekarzami i wiodącymi naukowcami z całego świata stawia sobie za cel rozwój badań naukowych. Nasze skoncentrowanie się na neuronauce, olbrzymie doświadczenie naukowe i odwaga w podejmowaniu ryzyka czynią z nas liderów w pracach badawczych i rozwojowych leków, dzięki czemu neuronauka może przynieść więcej korzyści dla społeczeństwa.
#LI-Hybrid
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.
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)