Principal Medical Writer
Syneos Health
Associate Director, Medical Writing
ImmunityBio, Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $130,000 - $150,000 per year
Job Level
Senior
About the role
- Lead day-to-day activities of medical writing team; train, coach, and monitor performance.
- Assist Director, Medical Writing with strategic planning, resource allocation, and standardizing policies for regulatory document drafting and finalization.
- Plan, manage, and prepare internal and external communications of scientific and clinical data including abstracts, posters, presentations, manuscripts, congress materials, and educational/training materials.
- Serve as medical writing lead and subject matter expert on multiple concurrent complex writing assignments.
- Work closely with in-function and cross-functional teams on document strategies and regulatory submission strategies.
- Draft, edit, and finalize regulatory documents (protocols, IBs, CSRs) for FDA submission and global regulatory submissions.
- Develop and implement Scientific Communications SOPs and ensure publication activities align with strategic initiatives and industry best practices.
- Lead project team and document review meetings; provide direction and solutions to cross-functional teams on document content and expectations.
- Ensure quality, consistency, alignment, and compliance of regulatory documents and publications, including eCTD formatting and hyperlinking.
- Perform ad-hoc and cross-functional projects to support business needs and provide developmental opportunities.
Requirements
- Bachelor’s Degree in a science-related field with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or Masters’ Degree in a science-related field with 8+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or PhD in a science-related field with 6+ years of relevant industry experience in medical writing in the healthcare industry or academia required
- Demonstrated experience in guiding medical writing efforts for clinical development of one or more investigational products required.
- Demonstrated expertise in writing and editing regulatory documents (clinical study protocols, IBs, CSRs) is required
- Experience in NDA/BLA submissions and writing CSRs, IBs, clinical study protocols and other documents for global regulatory submissions is required.
- Experience and strong scientific background in oncology, immunotherapy, or related field is required.
- Prior experience in the biopharmaceutical industry preferred
- Understanding good publication practices and guidelines, ie, ICMJE, GPP3, etc.
- Proficient knowledge of AMA style guidelines.
- Extensive knowledge of FDA, EMA, and ICH guidelines.
- Deep understanding and knowledge of the drug development process
- Ability to manage multiple projects and priorities simultaneously, meet deadlines, and adjust to shifting priorities in a fast-paced environment.
- Established proficiency with principles of clinical research and expertise in the interpretation and presentation of clinical data and other complex information.
- Ability to work cross-functionally and lead teams.
- Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly and compellingly.
- Disciplinary expertise in oncology, immunology, and/or infectious disease.
- Strong critical and logical thinking skills with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
- Ability to work independently and collaboratively: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines
- Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates.
