About Us

About the Role

As the Associate Director, Pharmacovigilance, you will work closely with the Safety team to support ongoing clinical trials.

This role is critical in ensuring patient safety and regulatory compliance throughout the drug development lifecycle. Day to day, you will work closely with safety physicians, clinical teams, and external stakeholders to manage safety data and contribute to safety oversight. You must have experience reviewing adverse events, safety signals, and coordinate/contribute to the Safety Review Committee (SRC) and Drug Safety Monitoring Boards (DSMB) meetings. You must have experience supporting clinical pharmacovigilance activities and working with DSMBs in order to be successful in this role.

This is a unique role that will allow you to work collaboratively with the growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus elevate the care of our patients' lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely within the United States.

Key Responsibilities

Safety Data Review

• Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs.
• Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees.
• Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity.

Cross-functional Communication & Collaboration

• Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports.
• Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items.
• Contribute strategically to the preparation of aggregate safety reports such as the DSUR.
• Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit–risk evaluations.
• Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication.

Documentation & Compliance

• Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies.
• Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation.
• Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories.

Experience

• Education: PharmD or RN degree required.
• Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry.
• Proven experience reviewing adverse events and working closely with safety physicians.
• Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
• Proficiency in Microsoft Office Suite and Microsoft Teams, with the ability to leverage these tools for efficient communication, scheduling, and documentation
• Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines).
• Excellent analytical, organizational, and communication skills.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
• Fluency with Argus safety database
• Familiarity with rare disease or oncology programs.
• Prior experience in a start-up or small biotech setting.

Position Summary:

The Associate Director, Clinical Quality Assurance, will report to the Executive Director, Quality Assurance. The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and ensuring quality practices are effectively implemented across clinical programs.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides quality oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions. The individual partners closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development function and  serves as a key member of study teams, helping identify quality issues and risks,  and reviews quality events, investigations, and CAPAs; analyzing quality signals across studies and vendors that support risk-based decision making, and ensuring quality management practices are appropriately implemented throughout the clinical trial lifecycle.

The role operates with a high degree of independence in evaluating quality risks and compliance considerations while collaborating closely with cross-functional teams to support effective implementation of quality practices across clinical development programs.

The position contributes to strengthening the organization’s maturing Quality Management System (QMS) by supporting procedural governance, audit program oversight, and quality process improvement initiatives.

Responsibilities:

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
• Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
• Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
• Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
• Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
• Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred.
• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
• Strong applied knowledge of global GxP regulations applicable to clinical development, including:
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GVP)
  • Good Laboratory Practice (GLP)
  • GMP experience is not required for this role
• Experience with the following is desired:
  • Quality management and oversight of clinical trials
  • Quality event and CAPA management
  • Regulatory inspection readiness and inspection support
  • Risk-based quality management approaches
  • Planning of clinical audits (including sites, internal audits)
  • Developing metrics and reviewing issues for quality signals and trends
  • SOP governance through controlled document reviews
  • Training matrix or training governance activities
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Position Summary:

The Senior Director, Risk Management, Drug Safety & Pharmacovigilance (DSPV) will report to the Vice President, Drug Safety & Pharmacovigilance and will be responsible for our Risk Management strategy and Benefit Risk Office at Vera which strives for excellence and the creation of a best practice framework. As a Risk Management Lead, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and other Benefit Risk deliverables. The overall goal of the Risk Management Lead is to optimize the proactive impact made by the PV department at Vera while maximizing patient safety and minimizing/preventing patient risk.

Responsibilities:

• Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV.
• Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
• Provide recommendations and guidance through subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment documentation.
• Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
• Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations.
• Remain up to date and well informed on all Regulatory intelligence as it relates to risk management and relay this to the Project team and the PV medical safety science team.
• Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation Strategy (REMS).
• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments.
• Provide guidance on incorporation of the patient’s perspective into benefit-risk activities (e.g. Real-World Evidence studies with Medical Affairs).
• Collaborate with PV Physician Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross-functional teams on benefit risk assessment strategy.
• Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program.
• Provide guidance and drive the creation of tracking risk management commitments including utilization of a tracking spread sheet or platform and improvement assessments
• Monitor and report risk management metrics to ensure compliance.
• Provide centralized support, training, and leadership for safety and cross-functional members who work on risk management plans and risk minimization activities.
• Support inspections and audit activities internally and externally with regards to risk management processes.
• Perform other duties as defined in standard operation procedures or requested by supervisor.
• Work with PV Physician and PV Scientists to aide in the proper characterization and classification of Risk from initial signal to evaluation, validation, implementation in study documents, protocols, IBs, ICFs, and RMPs.
• Work with VP of DSPV, PV Physicians and PV Scientists on any Regulatory Submission/filing for BLA, SBLA, MAA, etc. to be sure that risks are reflected properly and carried through to support filing activities.
• Oversee risk components of Aggregate reports like DSUR, PBRER etc.
• Work with PV Physicians and PV Scientist in risk presentations at safety Governance meetings (MSRB & MSRC) to ensure proper communication of risk is achieved and proper course of action is followed.
• Manage and oversee any outsourced RMP related activities to external vendors.

Qualifications:

• PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience.
• Minimum 5-10 years in PV/safety OR clinical development preferred.
• Minimum 5-10 years of pharmaceutical industry/drug development experience.
• Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred.
• Strong track record of scientific and analytical thinking.
• Experience presenting at meetings is desirable.
• Work with integrity and work proactively in a fast-moving environment.
• Good Critical thinking skills. Ability to use good analytical/judgment skills to understand, analyze, and communicate.
• Project Management Skills with ability to manage both time and priority constraints and to manage multiple priorities simultaneously.
• Attention to detail, computer literacy, knowledge of safety databases.
• Good working knowledge of all the functions within PV from PV operations onto medical safety science and all processes in between.

The TMF Manager will report to the Executive Director, Clinical Quality Assurance and will support the quality and integrity of the Trial Master File (TMF) and electronic Trial Master File (eTMF) across clinical programs. This role helps ensure clinical trial documentation is complete, accurate, and maintained in accordance with regulatory requirements and industry standards throughout the clinical trial lifecycle.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides independent oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides oversight of Trial Master File management to ensure clinical trial documentation is organized, complete, and maintained in a state of continuous inspection readiness for our Vera studies. The individual partners with study teams, functional document owners, and system users to monitor TMF health, identify documentation gaps, and support effective TMF management throughout the lifecycle of clinical studies.

The position also serves as the eTMF system administrator and collaborates with Clinical Quality Assurance leadership to support system governance, implement improvements through appropriate change control processes, and provide training and guidance to study teams and functional stakeholders.

The role operates with a high degree of independence in monitoring TMF quality and completeness while working closely with cross-functional teams to ensure documentation practices align with regulatory expectations and organizational procedures.

Responsibilities:

• Provide oversight of Trial Master File management across clinical development programs and functions. The position partners closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF. Partner with study teams, functional document owners, and system users to facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
• Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. In addition, the position supports TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
• Contribute to establishing and maintaining consistent TMF management practices across studies and programs to support alignment with regulatory expectations and industry best practices.
• Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
• Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies, ensuring appropriate governance of TMF practices across study teams and functional document owners.
• Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management
• Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality to support TMF quality and inspection readiness.
• Support regulatory inspections and internal audits involving TMF records and management, including providing eTMF navigation and demonstration of TMF document structure and audit trail traceability.
• Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
• Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

 Qualifications:

• Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or related scientific discipline or commensurate work experience managing TMFs.
• Pharmaceutical, biotechnology, or CRO experience with direct involvement in Trial Master File management desired.
• Strong knowledge of regulatory requirements and industry expectations related to clinical trial documentation and Trial Master File management.
• Trial Master File (TMF) oversight and electronic TMF systems.
• Clinical trial documentation requirements and the TMF Reference Model.
• TMF health review and document completeness monitoring.
• Regulatory inspection readiness and inspection support.
• Cross-functional collaboration with clinical development functions.
• Working knowledge of global Good Clinical Practice (GCP) requirements and regulatory expectations for clinical trial documentation.
• Experience contributing to:
  • TMF process improvement initiatives
  • eTMF system administration or system governance
  • TMF metrics development and monitoring
  • TMF closeout and archival processes
• Experience working with CROs or vendors responsible for TMF activities.

Job Title: Senior Scientific Communications Manager        

Location: Remote          

Role Overview: We’re looking for a Senior Scientific Communications Manager to join our growing biotech team. This is a hands-on role for someone who enjoys turning complex scientific and clinical information into clear, accurate, and useful communications for a variety of audiences.

At a small startup, this person will wear multiple hats. You’ll help shape our scientific story externally and internally, while also building and supporting core Medical Information capabilities. That means creating high-quality scientific materials and helping ensure that medical inquiries are addressed in a timely, accurate, balanced, and compliant way.

This role is a great fit for someone who is scientifically strong, highly organized, comfortable with ambiguity, and excited to build processes in a fast-moving environment.

Key Responsibilities: 

Scientific Communications

• Develop and refine clear, compelling scientific messaging across programs and stages of development
• Draft and manage scientific content such as:
• slide decks
• congress materials
• medical Information letters
• medical affairs and training materials
• FAQs and background documents
• external sci comm projects (e.g. webinars, podcast, product theaters, symposia)
• Translate preclinical, translational, and clinical data into audience-appropriate communications
• Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, and company leadership to ensure scientific accuracy and message consistency
• Help prepare materials for advisory boards, investigator meetings, and scientific congresses
• Contribute to the development of the company’s scientific narrative as programs advance

Medical Information

• Help build and maintain core Medical Information content and processes in an early-stage company environment
• Develop, review, and update standard medical response documents and reference materials
• Research and synthesize literature and internal data to support responses to unsolicited medical inquiries
• Ensure responses are accurate, balanced, evidence-based, and compliant with internal and external requirements
• Partner with Medical Affairs, Regulatory, and Pharmacovigilance to support appropriate documentation and escalation of medical inquiries, adverse events, and product complaints, as applicable
• Maintain a library of response letters, FAQs, and scientific references
• Identify trends in incoming medical questions and share insights with internal stakeholders
• Support training of internal teams on scientific messaging and Medical Information processes
• Help manage external Medical Information vendors or agency partners, when applicable

Other Requirements: the ability to travel at least twice yearly to company all hands meetings and optionally to scientific conferences where you feel your presence is of value

Qualifications: 

• Advanced degree in life sciences preferred
• Approximately 5+ years of relevant experience in scientific communications, medical communications, medical affairs, medical information, or a related biotech/pharma function
• Experience in dermatology or immunology strongly preferred
• Strong scientific writing and editing skills, with the ability to tailor content to different audiences
• Solid understanding of drug development, clinical research, and interpretation of scientific data
• Experience supporting scientific communications deliverables such as presentations and congress materials
• Experience developing or reviewing Medical Information content is strongly preferred
• Strong attention to detail and commitment to scientific accuracy and compliance
• Able to work independently, manage multiple priorities, and adapt quickly in a startup setting
• Experience working with vendors, medical writers, or outsourced contact center/Med Info partners
• Collaborative, practical, and comfortable working across functions with limited structure

Qualifications:

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• Advanced degree in life sciences preferred
• Experience in the dermatology or immunology therapeutic areas highly preferred
• 5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment
• Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes
• Strong experience managing scientific publications, including manuscripts, abstracts, and posters
• Demonstrated experience working with and managing external medical writing vendors or publications agencies
• Strong understanding of publication planning, congress execution, and scientific data communication
• Excellent project management skills with the ability to manage multiple complex deliverables simultaneously
• Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback
• High attention to detail and commitment to scientific accuracy, quality, and compliance
• Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment
• Ability to operate with autonomy and help build processes where structure is still evolving
• The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

About Us

About the Role

The Director, Clinical Quality Assurance (QA), will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.

Reporting to the Sr. Director, Clinical QA, you will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities (e.g. ICH, FDA, EMA, MHRA, etc.)

You will partner cross-functionally with Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, Bioanalytical, CMC, and Regulatory Affairs teams, while working closely with other functions of the Quality Unit (e.g. Clinical Quality Systems and Quality Systems and Compliance) to ensure the global GCPs are met for our clinical studies and to support inspection readiness and quality system alignment. Your role will be integral in assuring Dianthus is always inspection ready. You must possess experience and skill collaborating and influencing CRO’s, laboratories, and other clinical vendors in order to be successful in this role.

This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III).
• Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out.
• Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.)
• Provide expert guidance on quality risk management, issue escalation, and mitigation strategies.
• Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors.
• Ensure effective oversight of delegated activities, including monitoring, data management, and safety management.
• Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends.
• Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits.
• Align audit strategy with clinical milestones and BLA readiness.
• Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution.
• Ensure data integrity principles (ALCOA++) are embedded across clinical programs.
• Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation.
• Participate in regulatory inspections as a QA subject matter expert.
• Act as a trusted advisor to Clinical Development and Operations leadership.
• Drive a culture of quality, compliance, and continuous improvement.
• Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components.
• Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs.
• Lead or contribute to quality governance forums and risk review boards.
• Identify and assess systemic quality risks and compliance gaps
• Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings.
• Escalate critical risks to senior leadership with clear, risk-based recommendations.
• Additional duties may be identified by functional management based on current project/business objectives.
• Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

Experience

• BS or MS degree in life sciences or related field required.
• 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry.
• Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.)
• Significant experience supporting global clinical trials (e.g. Phase I, II and III).
• Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO).
• Deep expertise of Sponsor oversight and CRO/vendor management responsibilities.
• Deep expertise in data integrity principles and risk-based quality management.
• Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management.
• Experience working with or managing eQMS platforms and quality processes.
• Knowledge of Clinical Quality Systems.
• Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks.
• Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical.
• Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations.
• Ability to translate regulatory expectations into practice, risk-based solutions.
• Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.

Principal AI Solutions Consultant

Our client is a healthcare organization specializing in Patient Support Programs, looking for a Principal AI Solutions Consultant to join their team on a contract basis. This is a practical, results-driven role focused on developing AI-powered automations and MVP solutions that streamline operations and enhance program visibility.

In this role, the Consultant will partner with Project Managers, Operations, and Clinical teams to turn real operational challenges into effective, user-friendly tools built on Microsoft 365, Power Platform, and large language models. Note that compliance, pharmacovigilance, DPIA, and patient data handling fall outside the scope of this role — those responsibilities sit entirely with the client's internal teams.

What You'll Be Doing

The Consultant will own the end-to-end delivery of focused, high-value MVPs and automations across 2–3-week sprints, with structured demos and knowledge transfer at each cycle. The engagement will span across 6-8 weeks, and full-time work may be available after this period. Work will span:

• Building a Trust Engagement Database leveraging tools such as Notion, SharePoint, or equivalent platforms.
• Developing Power Automate workflows and Copilot Agent assets — covering prompt libraries, lightweight agent frameworks, automated SLA reminders, email and Teams-based triggers, tracking dashboards, and recurring or on-demand reporting.
• Prototyping LLM-assisted Adverse Event (AE) triage workflows (non-PHI), encompassing classification and summarization logic, intelligent routing, and retrieval from approved content sources.
• Wrapping up solutions as reusable, well-documented components: data models, deployment runbooks, and step-by-step how-to guides.
• Working hand-in-hand with Project Managers and Operations to make sure every solution lands well and can scale.
• Contributing to the client's AI-driven Digital Transformation initiatives.

What We're Looking For

• Proven track record delivering production-ready automations within the Microsoft 365 ecosystem (SharePoint, Teams, Power Automate, Power BI).
• Hands-on experience working with LLM-based tools, prompts, or agent frameworks (Azure OpenAI, Copilot, Claude, or similar).
• Strong command of data modeling using Notion, Excel, CSV, and Microsoft Graph.
• History of shipping MVPs on tight, sprint-based timelines.
• Comfortable working in a contract/consultancy capacity. You must be available for 6 to 8 weeks of work, with the potential of staying on as a full-time staff member afterward.
• Background in pharma or healthcare — particularly familiarity with industry terminology — is a significant plus.

Nice to Have

• Experience integrating HubSpot or Microsoft Graph into existing workflows.
• Knowledge of evaluation frameworks for classification and summarization tasks.
• A portfolio of reusable internal tooling built for external clients.

Working Style & Values

• Able to navigate non-PHI environments confidently and responsibly.
• Highly organized with a sharp ability to prioritize under pressure.
• Thrives in dynamic, fast-moving settings.

Our client is a values-driven organization in the healthcare space, guided by the principles of caring, candor, and high performance. They are seeking someone who welcomes feedback, adapts their approach based on team input, and brings both conviction and humility to collaborative problem-solving.

if this sounds right for you, use the form below to apply!