**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** 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. **Location/Division Specific Information** Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives. **Discover Impactful Work:** Accountable for all study investigational medical product (IMP), including oversight of the receipt, dispensing and return of used/unused IMP, ensuring correct storage, complying with company SOPs and COPs and identifying opportunities for process improvement. Consistently serves as a source of clinical expertise to investigators, clinic and support staff, client services, sponsors, and others as needed. In coordination with departmental management team, coordinates interdepartmental communications, supports departmental training and adherence to regulatory educational requirements, as well as supports departmental QA/QC functions. **A day in the Life:** + Dispenses IMP on all studies according to local regulations, sponsor written instructions and SOPs. + Provides training to patients on self-administrating of IMP. + Oversees all study IMP and maintains accountability logs per study/sponsor requirements. + Serves as pharmacy lead on incoming clinical study protocols; plans and prepares for accurate dosing including packaging, preparation, and administration of doses. + Ensures adequate supplies of clinical samples are retained with documentation of random selection procedure, as required for study. + Serves as liaison and consultant to sponsors concerning pharmacy details for future and current protocols. + Interacts as a vital member of the site team offering guidance on pharmacy procedures and operations specific to each protocol. + Serves as departmental resource for pharmacy-related clinical inquiries from investigators, clinic and support staff, client services, sponsor companies, and others as needed. + Participates in cross-training activities with other departments. + Collaborates with management on improving department processes and + procedures. + Ensures adherence to corporate procurement procedures. + Ensures correct storage of IMP on each study and maintains temperature logs in the dispensary. Manages temperature excursions and reports thereof as per sponsor’s written instructions and internal SOPs. + Oversees the safekeeping of code break envelopes. + Returns used and unused IMP to the sponsor/depot as per written instructions. **Keys to Success:** **Education and Experience** + Bachelor's degree in Pharmacy or Pharm D degree + Must hold a valid pharmacy licence within the country operating. Must be registered with local health care authority. + Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’). **Knowledge, Skills, Abilities** + Expert knowledge of important regulatory considerations + Proven ability to assess the safety and tolerability of different classes of drugs + Expert knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies + Demonstrated ability to work independently, analyze and work with attention to detail, processing and prioritizing sensitive and complex information and problem solving + Advanced analytical ability + Demonstrated ability to exercise discretion and sound judgement + Effective strong decision-making, negotiation and influencing skills + Excellent organizational skills and detail-orientated leadership approach + Proficiency in basic computer applications + Effective interpersonal skills to work in a team environment + Excellent communication skills with Czech and English Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.