ImmunityBio, Inc.

Auditor

• Ensure GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols
• Interact cross-functionally with functional teams in Clinical Trials including Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements
• Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices
• Contribute to the development and review of SOPs and other controlled documents
• Ensure compliance with SOPs and ICH GCP E6 (R2) standards
• Manage the incident management program through monitoring of complaints, deviations and CAPAs
• Schedule, plan, coordinate, and conduct audits (vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits)
• Prepare required documentation to support audit activities
• Validate accuracy of audit findings and ensure satisfactory resolution of non-compliance issues
• Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs
• Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance
• Support training on company procedures, GCP regulations, and documentation systems
• Maintain QA department spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files

Senior GCP Auditor

Director

• Accountable for setting strategic and tactical direction to drive clinical conviction of Anktiva for their area field sales team
• Achieve yearly sales performance targets within the bladder cancer market
• Create impactful and collaborative area business & account plans
• Lead, empower, and direct a field team of Uro Oncology Business Managers
• Design and implement short and long-term business plans to achieve commercial objectives
• Achieve promotional objectives through execution management of marketing strategies
• Hire and coach team members for designated territory as needed
• Develop solutions to help address BM business challenges
• Assess competitive promotional activity and treatment adoption
• Develop key customer relationships through regular interaction

Area Business Director – North Central

Content Writer

• Serve as a subject matter expert; and as the medical writing lead on complex writing assignments within and across departmental team(s) on document strategies.
• Lead project team meetings and document review meetings, follow up on actions, and provide direction and solutions to cross-functional teams on expectations for document content.
• Adhere to established regulatory standards, as well as company Standard Operating Procedures (SOPs), client standards, and company approved templates when completing medical writing projects, on-time and on-budget.
• Write, edit, and finalize clinical and nonclinical publications, manuscripts, journal abstracts, congress materials, educational/training materials, and other external-facing documents.
• Serve as peer reviewer providing review comments to give maximum clarity of meaning, accuracy, relevance and to ensure that medical communications objectives are met.
• Ensure that all publication activities are of high scientific and medical quality and meet Good Publication Practices standards, align with SOPs and are documented appropriately.
• Manage the development and execution of a “rolling” strategic publication plan for clinical and real-world evidence (RWE) studies, ensuring alignment with the medical and clinical development strategy and adhering to industry best practices (e.g., GPP, ICMJE, PRISMA, CONSORT, etc.).
• Lead the development, review, editorial, approval, and submission of manuscripts, abstracts, posters, and presentations across clinical trials, real-world evidence studies, and health economics outcomes research (HEOR).

Principal Medical Publications Writer

Analyst

• Create systems and pipelines to collect and transform data into reliable and accessible datasets.
• Develop data models for analysis, produce data analytic solutions, and automate reports.
• Design, build, and maintain pipelines integrating various medical and pharmacy data.
• Apply rigorous data quality, deduplication, and crosswalk logic.
• Partner with the IT team to enhance scalable environments.
• Collaborate with IT to design dashboards.
• Develop Excel solutions to reduce manual effort.

Senior Analyst, Business Analytics

Research Analyst

• Participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies
• Develop, review, and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create/edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
• Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
• Partner with field CRAs and CTAs to resolve issues identified during site visits
• Train vendors, investigators, and study coordinators on study requirements
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide data listings and compile clinical study report documents to support medical writing activities
• Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations

Clinical Research Associate II, Field Monitor

QA Engineer

• Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures in support of disposition of manufactured product.
• Document, manage and support issue resolution associated with batch review.
• Perform inspection and release of incoming raw materials according to appropriate material specifications and standard operating procedures.
• Perform Quality Assurance activities to support Manufacturing operations, including but not limited to product label issuance/reconciliation, batch record issuance, Starting Material (i.e. Cell Banks) Receipt, Release and Inventory Management, Logbook (i.e. Equipment Use, Facility Cleaning) Issuance and Management.
• Perform Product Complaint Investigations to determine root cause and identify/implement related Corrective and Preventative Actions.
• Initiate Quality Deviation and perform robust investigation to determine root cause and identify/implement related Corrective and Preventative Actions.
• Initiate and Own Quality Change Control, complete associated implementation task assignments and provide supporting documentation for completion of change records.
• Perform Manufacturing Floor Observations (including Practice vs. Procedures, Aseptic Technique and Media Fill Observations) to ensure inspection readiness.
• Identify Continuous Improvement Activities and implement changes to enhance the overall Quality Systems, Procedures and Oversight of GMP Operations.
• Support both Internal and External Compliance/Regulatory Audits.
• Maintain compliance with all assigned training requirements and train others as assigned.
• Create, Draft and/or revise SOPs, Work Instructions, and other controlled document types, as assigned.
• Collaborate in cross-functional team meetings to resolve quality issues.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

QA Specialist, Quality Operations

• Participate in clinical research teams to ensure effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support
• Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create/edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution
• Collect study and site metrics and maintain study trackers
• Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
• Communicate regularly with field Clinical Research Associates to provide information before and after site visits
• Partner with field CRAs and CTAs to resolve issues identified during site visits
• Work with Supply Chain to ensure sites maintain sufficient investigational product and resolve IP temperature monitoring excursions and train or assist sites with corrective actions
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide data listings and compile clinical study report documents to support medical writing activities
• Create and/or review of slides, overheads, etc., for project, departmental, sponsor and/or business development presentations
• Provide support and escalate issues to the Clinical Trial Manager as appropriate
• Performs other duties as assigned

Clinical Research Associate I, Field Monitor

• Participate in clinical research teams to ensure effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support
• Develop, review and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create/edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Collect study and site metrics and maintain study trackers
• Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed
• Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits
• Partner with field CRAs to resolve issues identified during site visits
• Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) and resolve IP temperature monitoring excursions and train or assist sites with corrective actions
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Clinical specimen log review and coordinating shipment of specimens to the sponsor or contracted vendor
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide mentorship and training to newly hired research staff
• Perform other duties as assigned

Senior Clinical Research Associate, Field Monitor

• Lead day-to-day activities of medical writing team; train, coach, and monitor performance.
• Assist Director, Medical Writing with strategic planning, resource allocation, and standardizing policies for regulatory document drafting and finalization.
• Plan, manage, and prepare internal and external communications of scientific and clinical data including abstracts, posters, presentations, manuscripts, congress materials, and educational/training materials.
• Serve as medical writing lead and subject matter expert on multiple concurrent complex writing assignments.
• Work closely with in-function and cross-functional teams on document strategies and regulatory submission strategies.
• Draft, edit, and finalize regulatory documents (protocols, IBs, CSRs) for FDA submission and global regulatory submissions.
• Develop and implement Scientific Communications SOPs and ensure publication activities align with strategic initiatives and industry best practices.
• Lead project team and document review meetings; provide direction and solutions to cross-functional teams on document content and expectations.
• Ensure quality, consistency, alignment, and compliance of regulatory documents and publications, including eCTD formatting and hyperlinking.
• Perform ad-hoc and cross-functional projects to support business needs and provide developmental opportunities.

Associate Director, Medical Writing

Accounting Manager

• Manage projects within manufacturing operations and Supply Chain; prepare standard cost reports and determine manufacturing variances
• Check bills of material for standard costs; assist with new product costing and cost roll
• Assist with month-end close and reporting; prepare journal entries and enter inventory A/P accruals
• Reconcile balance sheet and perpetual inventories to the general ledger; analyze variances
• Track daily work items in D365 and investigate/report inventory adjustments
• Assist Cost Director with annual budget process and annual physical inventories
• Support internal customers by researching questions and investigating variances on the financial statements
• Ensure proper retention, filing, and handling of accounting records; prepare reports and assist in special/ad-hoc projects
• Interact on-site with manufacturing, supply chain and quality team members; perform cross-functional projects as assigned