• Oversee and manage the controlled documents lifecycle and corresponding test assessments • Ensure compliance with internal policies and procedures and target review cycle frequency including appropriate formatting of SOP documents • Support SOP review and approval process as deemed appropriate • Oversee and manage training related activities (e.g. SOP table of content, training matrix, training decks, other training documentation) • Oversee and provide assistance with CAPA administrative activities (data entry, effectiveness checks, process improvement, ensure process is managed in compliance with policies and procedures, etc.) • Support and assist with GQC IT systems maintenance and change control (CAPA, electronic Document and Learning Management System, other) • Oversee and manage the Regulatory/Client Audit Support functions • Audit scheduling and audit calendar maintenance • Meeting coordination/logistics • CDA Requests • Auditor Code of Conduct • Setting up internal trackers and portals • Setting up and providing secure Box access for auditor(s) when required • Quality Compliance documentation review prior to and during audit • Ensure audit reports and responses are stored as per UBC record retention procedures • Provide administrative support (i.e., agenda, minutes, metrics) for the Global Quality Compliance department • Assist in department-related special projects • Other duties as assigned

Role Description The TMF Document Coordinator I plays a key support role in maintaining the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial. The TMF Coordinator I reviews and processes TMF records through quality control workflows to ensure they meet required quality, compliance, and regulatory standards before being approved into the TMF, following study-specific guidelines, SOPs, and ICH‑GCP requirements. - Review TMF records for completeness, accuracy, and quality prior to approval. - Classify records and assign appropriate metadata based on record type. - Identify quality issues, issue pre‑approval queries, and coordinate with submitters to ensure timely resolution. - Participate in TMF quality reviews and address assigned findings promptly. - Assist in maintaining study milestones and expected document lists. - Support the TMF Project Lead in generating monthly TMF metrics and related reports. - Attend internal TMF Focus meetings to provide updates on TMF status, issues, and outstanding queries. - Collaborate with project team members to resolve issues impacting TMF records. Qualifications - College degree. - Experience in clinical research within the biotechnology, pharmaceutical, or CRO industry. - Intermediate proficiency in English. - Computer skills and proficiency in Microsoft Word and Excel. - Good organizational skills with the ability to manage multiple assignments. - High attention to detail and accuracy. - Ability to meet established timelines, expectations, and objectives. - Adaptable and comfortable working in a multitasking environment. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Benefits - Flexible work schedule. - Permanent full-time position. - Ongoing learning and development. Company Description At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Indero is a Global Clinical Leader in Dermatology and Rheumatology. Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology with more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.

At DraftKings, AI is becoming an integral part of both our present and future, powering how work gets done today, guiding smarter decisions, and sparking bold ideas. It's transforming how we enhance customer experiences, streamline operations, and unlock new possibilities. Our teams are energized by innovation and readily embrace emerging technology. We're not waiting for the future to arrive. We're shaping it, one bold step at a time. To those who see AI as a driver of progress, come build the future together. The Crown Is Yours As a Director, Regulatory Compliance, you'll play a critical role in safeguarding the integrity of DraftKings' prediction markets. You'll operate at the intersection of regulation, surveillance, and operations, helping ensure markets are fair, compliant, and built to scale. In this role, you'll work closely with internal stakeholders and external regulators to monitor trading activity, guide regulatory strategy, and strengthen market oversight. Your work will directly shape a trusted, future-ready exchange in a rapidly evolving regulatory landscape. What you'll do as a Director, Regulatory Compliance - Conduct daily T+1 trade practice surveillance to monitor market activity and support the onboarding of new customers. - Prepare, draft, and submit regulatory filings, including rule amendments and new product submissions, to the Commodity Futures Trading Commission with accuracy and timeliness. - Identify, investigate, and escalate potential violations of Exchange rules in alignment with regulatory requirements. - Partner closely with the Chief Regulatory Officer to manage investigations, address trade practice violations, and support regulatory reporting. - Step in to provide leadership and oversight for the Market Regulation function in the absence of the Chief Regulatory Officer. - Build and maintain strong relationships with internal teams and external regulators to support ongoing compliance with applicable rules and regulations. - Act as the primary liaison between the Exchange and third-party providers to implement and enhance market surveillance systems. What you'll bring - At least 10 years of progressive experience in market regulation or compliance within a Designated Contract Market, futures commission merchant, broker-dealer, or regulatory oversight organization. - Deep understanding of trade lifecycles, including order processing, clearing, settlement, and reconciliation. - Strong attention to detail with the ability to manage sensitive, time-critical data accurately and responsibly. - Ability to operate independently while managing complex regulatory and operational priorities. - Familiarity with case management systems and market surveillance tools. - Interest in prediction markets, sports trading, or broader financial markets. Join Our Team We're a publicly traded (NASDAQ: DKNG) technology company headquartered in Boston. As a regulated gaming company, you may be required to obtain a gaming license issued by the appropriate state agency as a condition of employment. Don't worry, we'll guide you through the process if this is relevant to your role. The US base salary range for this full-time position is 160,000.00 USD - 200,000.00 USD, plus bonus, equity, and benefits as applicable. Our ranges are determined by role, level, and location. The compensation information displayed on each job posting reflects the range for new hire pay rates for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific pay range and how that was determined during the hiring process. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

• Provide day-to-day support for Regulatory Affairs activities and operations. • Assist with document organization, information management, and administrative coordination. • Support internal documentation systems (e.g., SharePoint libraries). • Compile and maintain information for external reporting. • Assist with tracking regulatory/standards updates. • Contribute to exploratory improvement initiatives (including evaluation of new tools and workflows). • Gain hands-on experience with regulatory requirements relevant to innovative therapies (e.g., cell and gene therapies).