Internship for Pharmacy Students/ Pharmazeut im Praktikum (PhiP) - 6 months Internship

Job Description

This Internship opportunity is suitable specifically for Pharmacy Students/ Pharmazeut im Praktikum (PhiP).

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Prepare, review, compile and submit under guidance regulatory application dossiers to relevant institutions (Competent Authorities, Ethic Committees, etc.) in DACH region in line with the applicable national regulations and act as a key contact, provide local expertise.
• Manage applications covering studies with medicinal products - pre and/or post marketing e.g., Post-Authorization Safety Studies (PASS) or Post Marketing Observational Studies (PMOS) as well as non-interventional studies (NIS) - or studies with medical devices.
• Manage initial study applications and substantial amendments or notifications.
• Help coordinate responses to regulatory authorities' questions with strict deadlines.
• Work with international teams to maintain timelines for start-up activities in alignment with global strategy.
• Participate in the development, review and editing, of patient facing materials, protocol synopses and amendments.
• Identify and escalate risks, develop proactive solutions to challenges.
• Maintain trial status information and trial related documents in documentation management systems (filing, tracking of application forms, informed consent forms, communication with authorities, etc.)
• Assist with maintenance tasks relating to regulatory compliance activities involving document archiving.
• Manage translations of study specific documents as required per national regulations and complete internal quality control process.
• Maintain electronic Trial master File (eTMF) according to International Committee on Harmonization - Good Clinical Practice (ICH-GCP) and internal Standard Operating Procedures (SOP).
• Gain and maintain knowledge of SOPs (standard operating procedures) and current regulatory regulations and guidelines in DACH region.

• Role-based training (up-to-date knowledge in the regulatory landscape, EU-CTR 536/2014, etc.)
• Mentoring initiative (experienced bodies)
• Regulatory Intelligence Management Database (RegView)
• Subject Matter Experts (SME) - EU-CTR 536/2014, Data protection, labeling (clinical trials requirements), Medical devices, BfS procedures, import/export, etc.

• Successfully completed 2nd state examination as part of the pharmacy degree (according to §1 AAppO)
• Effective communication skills (verbal and written) in German and English (both to C1 level at least)
• Excellent time management, planning and prioritization skills
• Ability to work in a team environment or independently
• Proactive and self-reliance working behavior
• Curious and enthusiastic individual with a growth-oriented mindset
• Fast decision-making ability and result oriented approaches
• Strong attention to detail
• Creative, flexible, agile working attitude
• Ability to work well under pressure, managing multiple tasks and handle sensitive information with a high degree of confidentiality
• Good IT skills and ability to learn appropriate software