As a Medical Writer Program Lead at Spark Therapeutics, you will have a pivotal role in leading and authoring clinical regulatory documents for Spark’s gene therapy programs. As part of the Regulatory Affairs organization, the Lead Medical Writer will lead the production of the written communications components of clinical regulatory submissions, such as INDs, NDAs, and MAAs, through collaboration with senior project staff. In this role, the Lead Medical Writer will efficiently drive key document messaging activities and build and deliver strategic communications plans to guide project teams to achieve high-quality successful regulatory agency approvals. Responsibilities Job Function and Description
- Authors complex documents that facilitate efficient review by Heath Authorities.
- Directs the entire document written communications portfolio required for multiple clinical projects (ie, INDs, global submissions, regulatory briefing and response documents, etc).
- Ensures that documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
- Ensures alignment of clinical submission documents to the proposed prescribing information.
- Works across departments to help set priorities for document preparation to deliver documents in the required timeframe.
- Collaborates with therapy area leads and authoring team to develop resourcing strategies for each document or submission.
- Leads a team of authors from vendor agencies to deliver the clinical components to a submission and provides mentoring and knowledge expertise for preparing any document type.
- Provides expertise to the organization and authors regarding the best presentation of information within documents, as well as the design and format of data displays.
- Drives continuous improvement projects for the Medical Writing Organization and provides a communications leadership perspective on operations improvement teams.
Education and Experience Requirements
- Participates in the preparation/revision of document templates, development of processes, and preparation/revision of SOPs and guidance documents.
- Performs quality control and editorial review of internally and externally written documents and participates in meetings at the document team and clinical sub-team levels.
- Develops and implement new best practices in medical writing as Spark grows.
- Bachelors degree with 15+ or Masters degree with 10+ years experience in a science-related field (eg, Biology, Chemistry, Nursing) and/or Technical Writing plus a science concentration 10+ years of relevant industry experience; OR an advanced science degree (eg, PhD, PharmD, MD) with 7+ years of relevant industry experience.
- Experience in one or more of the following Therapeutic Areas:Hematology, Rare Disease, Ophthalmology, CNS, Gene Therapy. Experience with Immunotherapy preferred, but not required.
• Experience in integrating complex data and scientific information from all phases of drug development into clinical regulatory submission documents.
Key Skills, Abilities, and Competencies
- Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses.
- Strong understanding of medical concepts in gene therapy and current standard treatments in Spark’s disease therapy areas.
- Strong knowledge of the drug development process, global regulations, and guidelines.
• Proven ability to organize and integrate complex scientific information into written documents, and ability to drive regulatory medical writing processes and technical and editorial standards across projects.
- Expertise in developing and applying regulatory and company guidances, processes, and standards to ensure efficient quality, delivery, and compliance of clinical documents.
- Ability to adapt to continuous change in the regulatory and communications environment.
- Excellent organizational/planning and problem-solving skills at the product level.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent ability to prioritize effectively to deliver results within reasonably established timelines
Internal and External Contacts
- Ability to work well with vendors and cross-functional teams.
- Have strong collaboration, negotiation, conflict resolution, and strategic influencing skills.
- Exhibits competent collaboration, conflict-resolution, and influencing skills.
- Works successfully with a low level of direct supervision.
This role supports the areas of clinical drug development, biometrics, regulatory affairs, and pharmacovigilance, among others.
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.