BioArctic AB jobb

We are looking for an IT Systems Specialist to take responsibility for all IT‑related aspects of BioArctic’s laboratory computer systems. This role does not own the full lifecycle of the computerized systems themselves; instead, it ensures that every system’s IT foundation is correctly set up, maintained, secured, documented and aligned with BioArctic’s requirements. Your focus is on the computers, configurations, integrations and technical environments that laboratory software depends on — ensuring researchers can focus on science rather than IT troubleshooting. This is a hands‑on, highly technical and operationally important role requiring excellent computer expertise, strong structure, and experience running production‑critical environments. Because the work is closely tied to physical instruments and lab‑connected computers, this is a fully on‑site role. Key Responsibilities Ensure each lab‑connected computer meets all technical and software‑specific requirements (OS, hardware, configuration, performance). Install, configure and validate laboratory software on BioArctic IT environments (when installation is owned by IT). Manage system‑level updates, patches, antivirus, security controls, compliance settings and general device hygiene. Maintain software licenses, machine configurations and version consistency in accordance with documented processes. Handle technical integration aspects (interfaces, connectivity, data transfers) between computers, instruments and backend systems. Collaborate with our hosting and infrastructure partner for VMs, server environments, storage, backup, and networking. Participate in onboarding of new computerized systems: qualification, installation, configuration and documentation. Your Background 5+ years of hands‑on administration of production‑critical IT systems (20+ computers/systems). Degree in Computer Science, Information Systems, Systems Engineering, or equivalent. Strong experience with: Windows OS and technical troubleshooting Active Directory / Entra ID Intune & compliance‑based device management IT security principles for endpoints and system environments Storage concepts, permissions, retention, and data access controls Understanding how systems communicate (interfaces, APIs, integrations, connectivity) Excellent ability to write clear, structured and system‑specific documentation. Strong sense of responsibility, precision and operational discipline. Meriting Experience Experience working in a GxP, regulated or quality‑driven environment. Knowledge of GAMP5. Experience supporting laboratory or scientific environments. Why This Role Matters BioArctic’s laboratory operations have grown quickly, and many systems now rely on a stable and well‑controlled IT foundation. Historically, system owners and lab staff have had to manage certain IT aspects themselves — despite this not being their expertise. This role fills that gap by creating a reliable, secure and well‑documented IT environment for each computerized lab system, ensuring: scientists can focus on science systems behave predictably compliance and integrity are safeguarded the technical landscape becomes structured, transparent and future‑proof Your work is essential to enabling efficient research and maintaining the high standards BioArctic is known for. What We Offer A meaningful and technically advanced role in a research-oriented biopharma company with highly skilled colleagues A chance to modernize and professionalize how BioArctic manages IT around lab systems Close collaboration with scientists, system owners, IT partners and internal teams A culture based on integrity, innovation, teamwork and scientific excellence On‑site work with modern facilities and close connection to the research environment This recruitment process is managed directly by BioArctic. We kindly decline contact from external recruitment agencies and vendors.

Role summary The Clinical Expert/Clinical Study Physician will provide medical leadership and oversight for clinical trials in patients primarily with a central nervous system (CNS) disorder. The role is responsible for strategic and operational medical aspects of assigned clinical development projects, study designs, sponsor safety surveillance and adjudication of clinical events, communication with investigators, health authorities, ethics committees, and potential other committees relating to study conduct. The role is also required to support regulatory safety reporting as applicable. The physician will work closely with Clinical Operations, Biostatistics, Biomarkers/Imaging experts in the Research Organization and Regulatory team members to ensure high-quality, GCP-compliant study design and conduct and the timely delivery of medically informed decisions. Close co-operation with the medical monitor and other relevant members of the CRO team deployed to conduct the study will be a further critical aspect of the daily work. The role will also provide updates on study progress and report data to relevant project and leadership teams in the company and as applicable present data at scientific congresses. The role is expected to ensure high quality medical leadership and expert input for Early Project Teams to ensure that Target Product Profiles and Early Clinical Plans for Research projects are based on medical insights on unmet medical needs as well as emergent scientific developments in the field. Key responsibilities Ensure high quality strategic and operational leadership and expert input to assigned clinical development projects. Contribute to/be responsible for clinical study design, informed consent forms, investigator brochures and study manuals with specific indication-relevant medical input. Provide day-to-day medical oversight of the assigned clinical studies. Review and adjudicate adverse events, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs); support preparations of regulatory safety reports and aggregate safety analyses. Establish and maintain study and program safety management and medical monitoring plans, escalation pathways and Risk Evaluation and Mitigation Strategy actions as required. Provide medical input to investigator training and investigator meetings; answer medical queries from sites and global study teams. Support regulatory interactions and responses to health authorities on medical/scientific issues related to the study.   Qualifications Required: Medical degree, specialist in neurology and PhD is preferred. At least 5 years clinical experience including treatment of subjects with CNS disorders e.g. neurology, psychiatry, or internal medicine. At least 5 years experience in a Pharmaceutical Company as a Study or Program Physician with responsibility for on-going clinical trials, preferably in neurology indications. Demonstrated knowledge of ICH-GCP, SAE reporting requirements and clinical trial regulatory environment. Strong written and verbal communication skills in English. Preferred: Experience from leadership responsibility of clinical development programs in pharma development. Prior experience as a Clinical investigator. Experience with CNS-specific outcome measures, neuropsychological testing, imaging endpoints (MRI, PET) and biomarker interpretation. Experience interacting with Data Safety Monitoring Boards and writing medical sections of regulatory submissions (IND/CTA). Experience with electronic data capture systems and medical review workflows.   Core competencies Clinical judgement and rapid decision-making on patient safety. Leadership of clinical development teams. Clear, concise scientific and medical communication including in writing. Cross-functional collaboration and stakeholder management. Ability to interpret complex clinical and biomarker data. Ethical conduct and adherence to regulatory and GCP standards.   Reporting Reports to the Head of Clinical Development and Regulatory Affair. Works closely with colleagues in Clinical Development and Regulatory Affairs, as well as project leaders in Research & Development and other functions. Working conditions Full time position: expected on-site work at least 3 days/week. Flexible hours to support global trial teams across time zones when needed.