The main responsibilities of the Senior Scientific Writer will be to write and critically review nonclinical documents to support regulatory filings. The Senior Scientific Writer will also advance the medical writing capabilities of the company as well as strategies for document authoring. These tasks require the integration of research across different therapeutic areas and cross-functional coordination with internal stakeholders.
Other responsibilities will include:
- Develop strong working relationships with key internal stakeholders.
- Contribute scientifically at the project and/or study team level.
- Participate in relevant team meetings.
- Work with cross-functional teams to develop project objectives, strategies, timelines, and milestones.
- Participate in/lead document planning sessions including data analysis/visualization/ interpretation, document flow, key messaging, etc.
- Critically review scientific writing deliverables across a broad portfolio for clarity, accuracy, consistency, and alignment with company position; resolve issues, errors, or inconsistencies with pertinent team members to ensure optimal communication between teams.
Job Function and Description
Write/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.
Other assignments as required. Education and Experience Requirements
• Graduate degree (PhD preferred) in a relevant scientific discipline (i.e., cell biology, molecular biology, genetics, etc.).
- Minimum of 3+ years of experience in scientific/medical writing; experience in an industry setting (biotechnology, pharmaceutical, healthcare communications agency, etc.) is preferred.
Key Skills, Abilities, and Competencies
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- 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 a plus.
- Knowledge of drug development process.
- Familiarity with Microsoft Office, GraphPad Prism, and reference management software (eg, EndNote).
- Experience writing and managing the production of nonclinical documents.
- Knowledge of principles and processes of regulatory documentation.
Complexity and Problem Solving
- Ability to manage timelines and quality of work using strong organizational, communication, and interpersonal skills.
- Work successfully in a cross-functional project team; ability to facilitate discussions and decision-making with cross-functional team members.
- Proactive and collaborative mindset; exhibit an enthusiastic team attitude.
Internal and External Contacts
- Considered an expert in field within the organization.
- Develop solutions to complex problems which require the regular use of ingenuity and innovation.
- Ensures solutions are consistent with organization objectives.
The incumbent will collaborate with all therapeutic area leads, and all relevant departments involved in document filings and submission. Other Job Requirements
0-5% travel may be required
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. Nearest Major Market:
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.