We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.

We don’t follow footsteps. We create the path.

Primary Duties

The main responsibilities of the Lead Scientific Writer will be to independently write and critically review Research & Technology documents to support regulatory filings. The Lead Scientific Writer will also advance the scientific writing capabilities of the company by establishing or refining strategies for document authoring. These tasks require the integration of research across different therapeutic areas and cross-functional coordination with internal stakeholders.

Responsibilities

• Write/critically review study reports, coordinate writing efforts, and harmonize document writing processes.
• Coordinate the process of data review and visualization with therapeutic areas and cross-functional teams.
• Develop strong working relationships with key internal stakeholders.
• Identify internal and/or external business challenges and recommend best practices to improve products, processes, or services.
• Leverage understanding of company structure to bring together different functional areas to establish, harmonize, and/or synergize processes.
• Lead sub-streams or participate in large cross-functional project teams to solve complex problems by using analytical thinking, tools, and judgment to identify innovative solutions for Spark or an identified area within the company.
• Develop new approaches to complex problems and influencing others to change their point of view and leading others to solve the problem.
• Lead relevant team meetings.
• Lead document planning sessions including template development, data analysis/visualization/interpretation, document flow, key messaging, etc. Contribute scientifically at the project and/or study team level.
• Critically review scientific writing deliverables across the Research & Technology organization for clarity, accuracy, consistency, and alignment with company position; resolve issues, errors, or inconsistencies with pertinent team members to ensure optimal communication between teams.
• Serves as a mentor for colleagues with less experience.
• Other assignments as required.

Education and Experience Requirements

• Graduate degree (PhD preferred) in a relevant scientific discipline (e.g., cell biology, molecular biology, genetics, etc.).
• Minimum of 3-5 years of experience in scientific/medical writing; experience in an industry setting (biotechnology, pharmaceutical, healthcare communications agency, etc.) is preferred.
• Ability to interpret internal or external business challenges and recommend best practices to improve products, processes, or services.
• Ability to analyze and interpret complex data from a broad range of scientific disciplines; understanding of statistic fundamentals.
• Experience in gene delivery systems (especially, but not limited to, AAV-based gene therapy) and/or key therapeutic areas such as metabolic, ocular, and/or CNS disorders is a plus.
• Understanding of mechanisms underlying innate and adaptive immune responses upon in vivo gene therapy is preferred.
• Knowledge of AAV production, characterization, and/or analytical method development is preferred.

Key Skills, Abilities, and Competencies

• Knowledge of principles and processes of drug development and regulatory documentation.
• Experience writing and managing the production of nonclinical documents; serves as a best practices/quality resource.
• Technical expertise in typical office applications (Microsoft Office, Adobe Acrobat), GraphPad Prism, reference management software (e.g., EndNote), and shared document systems (e.g., SharePoint).
• Manage timelines and quality of work using strong organizational, communication, and interpersonal skills; ability to multitask.
• Communicate difficult concepts and negotiate with others to adopt a different point of view.
• Lead functional teams or (parts of) cross-functional projects with moderate resource requirements, risk, and/or complexity; ability to facilitate discussions and decision-making with cross-functional team members.
• Proactive, flexible, and continuous growth mindset.
• Considered an expert in the field within the organization.
• Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgment and identify innovative solutions.
• The incumbent will collaborate with all therapeutic area leads, and all relevant departments involved in document filings and submission.