uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The Associate Director Medical Writing contributes their scientific knowledge and analytical skills in the preparation and delivery of clinical regulatory documents and will produce high quality and timely writing deliverables, ensuring scientific consistency between related documents or studies in a clinical program. This role requires a strategic thinker who is insightful into clinical development. This position will lead the medical writing activities across a disease area or set of clinical programs.

Responsibilities

• Work with internal and external subject matter experts to plan, prepare, write, edit and finalize clinical and scientific documents, including clinical protocols, clinical study reports, investigator brochures, regulatory submissions including briefing documents, Investigational New Drug applications, Biologics Licensing Applications, and Marketing Authorization Applications.
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents. Help facilitate document strategies and messages in a collaborative way with relevant project team subject matter experts.
• Strong attention to detail and ability to complete writing assignments in a timely manner.
• Ability to work independently and collectively in teams.
• Provide QC of clinical and regulatory documents including data output.
• Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
• Ensure a consistent style for the presentation of clinical documents in order to maintain quality and ease of review, and adherence to company standards.
• Facilitate efficient review and finalization process of clinical documents produced internally and externally by consultants/contractors and vendors.
• Perform clinical literature searches related to documents in development.
• Ensure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and our company template.
• May provide support for medical communications projects as necessary, including drafting of publications, abstracts, manuscripts, and presentations
• May include participation in initiatives such as document template creation, writing style guide development, and support for document reviewing/authoring tools.
• Manage the work of external writing vendors or contractor writers, as needed.
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.

Qualifications & Skills

• PhD or MS in a Life Science or equivalent preferred, Bachelor’s Degree considered based on experience level.
• At least 5-7 years of clinical regulatory technical/scientific writing experience
• Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, IND clinical sections, regulatory submissions including briefing books.
• Background in gene therapy is a plus, but not required
• Ability to interpret and present clinical and scientific data and other complex information.
• Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
• Demonstrated ability to communicate clearly, concisely, and effectively.
• Ability to establish timelines for document creation and review, hold kick-off meetings, monitor team progress against original plans, and drive execution in a timely manner.
• Well-organized with the ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines

Core competencies

• Collaborative
• Enthusiastic and proactive
• Detail-oriented, highly organized
• Excellent problem-solving capabilities, solution oriented
• Dealing with ambiguity, interpersonal savvy, perseverance
• Informing and collaborative
• Flexibility to adapt to changing conditions
• Well developed sense of respect for others and business acumen