Associate Director, Medical Writing (CRO Oversight)

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

argenx is a clinical-stage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies, combined with the complementary expertise of our people, enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.

This individual will be responsible for the strategic and operational management of medical writing deliverables prepared by contract research organizations (CRO) or functional service providers. This role ensures that outsourced documents meet company quality standards, comply with regulatory requirements, and align with internal scientific and clinical messaging. The incumbent will provide onboarding and training support, document-level oversight, process governance, and vendor performance management and act as the key interface between in-house Medical Writing and external working partners.

Key Accountabilities/Responsibilities

CRO/Vendor oversight

• Serve as the primary point of contact for CRO medical writing teams and ensure alignment with company standards, timelines, and expectations

• Onboard and train CRO medical writers as needed

• Provide document-level guidance, review, and final approval oversight for CRO-authorized deliverables (eg, protocols, protocol amendments, clinical study reports, informed consent forms)

• Ensure consistent scientific messaging and adherence to company lexicon, style guides, and quality standards across outsourced deliverables

• Monitor CRO performance metrics (quality, timeliness, compliance), and participate in governance meetings, if applicable

• Identify training or quality improvement needs for vendor teams and coordinate targeted upskilling or remediation

Strategic Oversight and Quality Management

• Develop and maintain medical writing governance frameworks for outsourced deliverables, including SOPs, templates, and quality control/clinical editing processes

• Ensure alignment of outsourced documents with internal data strategy, key messages, and regulatory objectives

• Partner with cross-functional teams to ensure outsource writers have appropriate context and access to subject matter experts

• Contribute to vendor selection and evaluation processes, including defining medical writing requirements and KPIs

• Ensure quality review and continuous improvement initiatives within the medical writing outsource model

Team and Process Leadership

• Support internal writers and reviewers in effectively collaborating with CRO partners

• Participate in defining and refining the outsourced MW model

• Represent MW in vendor governance/operational review forums

Medical Writing Core Primary

• Engages relevant SMEs and document owners to directly author content that is well-organized, consistent, accurate, and appropriate for a regulatory audience

• Responsible for the inspection-readiness of medical writing activities

• Facilitates standardization of documents using document templates, lexicons, and the argenx style guide to ensure the quality and consistency of documents across programs

• Responsible for medical writers assigned to support the medical writing activities for a particular project

• Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them

• Capable of working on multiple deliverables simultaneously

Desired Skills and Experience:

• PhD or advanced degree in a scientific or clinical discipline or related field required;

• Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience required

• Strong organizational, communication, and influencing skills