Associate Director, Medical Writing – Clinical and Regulatory

This is a fully remote position, open to applicants in United States.

📋 Description

• Responsible for the development and execution of cross-functional contributions towards clinical and regulatory documents, which includes drafting, editing, reviewing, and guaranteeing the quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing materials.

• Ensures efficient, effective, and timely management of documents from inception (template) to completion (approval), which may involve first-draft authoring, literature and reference retrieval, editing, resolving comments efficiently, and overseeing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) while maintaining high quality.

• Actively participates as the Clinical Regulatory Writing representative in cross-functional project teams, providing input to ensure timely and accurate deliverables and negotiating timelines when necessary.

• Proactively implements practices for clinical transparency and disclosure in document development (e.g., Policy 70, Clintrials.gov, etc.) and collaborates with Clinical Trial and Transparency colleagues.

• Cultivates effective collaborative relationships with other essential functional stakeholders.

• Engages in departmental initiatives alongside other Clinical Regulatory Writing members to develop writing strategies and standards for implementation, taking responsibility for their execution.

• Synthesizes extensive clinical and scientific data into key elements suitable for tabular and graphical representation.

• Ensures all documents comply with relevant clinical and regulatory requirements, maintaining up-to-date knowledge of ICH and Health Authority guidelines.

⛳️ Requirements

• Bachelor’s, Master’s, or Doctorate degree in a scientific or medical discipline.

• Over six years of experience in the biotechnology/pharmaceutical sector.

• Proven experience in medical writing, editing, and clinical development; has authored protocols, investigator brochures, and clinical study reports; has participated in at least one eCTD/NDA submission is a plus.

• Strong leadership, planning, and project management capabilities, coupled with initiative and the ability to be productive with minimal supervision and limited administrative support.

• Demonstrated capacity to work effectively in a fast-paced environment with multiple high-priority projects.

• Proven track record of developing and implementing medical writing processes and standards.

• Outstanding oral and written communication abilities.

• Understands and effectively engages with diverse communication styles and business practices of alliance partners and internal colleagues.

• Adaptable; modifies work style to align with organizational needs.

• Strong organizational skills and experience in a multitasking environment.

• Motivated, self-directed, and capable of working independently as well as collaboratively to achieve ambitious organizational goals.

• Commitment to quality and reliability.

• Proficient in computer skills (Microsoft Office Suite, PowerPoint, Adobe Illustrator, figures and graphic design; Project and Visio are advantageous).

• Ability to establish and maintain effective partnerships, both internally and externally.

• Holds self and others accountable for upholding high ethical standards; maintains integrity and respect for colleagues at all levels.

• Experience with rare diseases and/or gene therapy is a plus.

• Willingness and ability to travel several times a year.

🏝️ Benefits

• Generous vacation time and public holidays recognized by the company.

• Volunteer days.

• Long-term incentives and employee stock purchase plans or equivalent options.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.