Senior Manager, Medical Writing

Role Summary

The Senior Manager, Medical Writing is responsible for directly authoring and/or leading the creation of high-quality medical and scientific documents that support development, regulatory approval, and commercialization for one or more products. The role requires collaboration with Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to ensure on-time deliverables that meet regulatory standards. Requires strong medical writing and scientific communications experience with understanding of early and late-stage drug development. Reports to the Head of Medical Writing.

Responsibilities

• Regulatory and Clinical Documents
• Author and/or manage the preparation of medical writing deliverables such as clinical study protocols, CSRs, IBs, eCTD written/tabular summaries, clinical overviews, briefing packages, Module 2 summaries, and IND enabling documents.
• Develop submission strategies in collaboration with stakeholders and ensure document preparation, review, and approval follow prescribed processes and conform with appropriate regulatory guidance (i.e., GCP, ICH guidelines, and eCTD requirements).
• Ensure timely and successful responses to health authority questions and/or requests.
• Authoring of ICF and other patient facing materials
• In collaboration with stakeholders, facilitate the redaction of clinical study protocols and other documents that fall within the scope of the implementation of EU-CTR.
• Publications
• Author and/or manage the preparation of manuscripts, abstracts, and posters for medical and scientific conferences and journals.
• Collaborate with subject matter experts and external authors to develop high-quality publications.
• Ensure publications align with strategic communication plans and company objectives.
• Process Development
• Develop and implement suitable document templates, style standards, and quality control checklists to ensure consistent and high-quality deliverables.
• Maintenance of relevant SOPs and internal best practices.
• Innovation and Digital Solutions
• Evaluate and drive adoption of innovative approaches in medical writing and communication strategies to aid in document development, review, and QC.

Qualifications

• Advanced degree (PhD, PharmD, MD) in a scientific discipline or related field preferred. Other relevant experience will also be considered.
• A minimum of 6 years of experience in medical writing and scientific communications within the pharmaceutical or biotechnology industry; oncology experience a plus.

Knowledge And Skills

• Knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA, AMA style guide).
• Excellent writing, editing, and verbal communication skills.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Proficiency with medical writing software and tools.
• Exceptional attention to detail and a commitment to excellence.
• Strong business acumen and a deep knowledge and understanding of the drug development process.
• Experience managing vendors and contractors a plus.
• Strategic thinker with strong analytical skills and ability to work in a fast-paced environment.
• Collaborative and able to build effective working relationships across the organization and with external stakeholders and collaborators.
• Strong ethical standards and integrity.

Education

• Advanced degree (PhD, PharmD, MD) preferred.

Additional Requirements

• Washington State Pay Range: $168,934 - $202,671 USD