An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for a Director of Technical Writing to join the Regulatory team and lead the company's technical writing activities, including regulatory and clinical documents. This is a key role directly supporting the company's development programs. The ideal candidate will have experience with a broad range of clinical and preclinical projects and documents, including clinical protocols, regulatory submissions, and scientific presentations. This is an exempt, full-time position located remotely with the expectation of traveling to corporate headquarters in San Diego, CA.
Responsibilities:
Lead the company's technical writing activities that support the preparation of regulatory and clinical documents for the company's global product development programs.
Collaborate with cross-functional representatives to develop and optimize systems and processes related to document development and management.
Serve as the primary technical writing representative on assigned product teams.
Closely collaborate with cross-functional representatives and subject matter experts, e.g. clinical, regulatory and scientific departments to manage the quality, accuracy and timely production of documents in compliance with internal and external standards, including but not limited to investigational new drug (IND) applications, clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical and regulatory documents, including regulatory summary documents.
Translate complex scientific and technical information into clear and concise content suitable for the target audience.
Develop, implement, and manage templates and documentation format required for standardization of regulatory and clinical documentation.
Follow regulatory guidelines and industry best practices to ensure all documentation meets required quality and compliance standards.
Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide and poster presentations for scientific congresses.
Coordinate and conduct interdepartmental team review and finalization processes of document deliverables including distribution of drafts, chairing review/adjudication meetings, incorporating revisions post-review, documenting key project events, and completing sign-off procedures.
Create and maintain audit system/trails of all document changes.
Coordinate and manage documents to produce submission ready content (SRC) for electronic publishing.
Ability to liaise with external services and review documentation generated externally, e.g., Clinical Research Organizations (CROs), co-development partners, and internally, e.g., for the preparation of tables, illustrations, and appendices.
As applicable, manage and train other internal and consultant technical writers and editors on company document preparation processes and systems.
Qualifications:
Bachelor's degree in a relevant discipline and at least 8 years of related experience as a technical writer in the pharmaceutical and/or biotechnology industry.
Broad range of experience in pre-clinical and clinical projects including regulatory documents, clinical protocols, and scientific presentations.
Working knowledge of clinical research, study design, and ability to present data objectively in a clear, concise written format.
Demonstrated scientific and analytic working knowledge of immunology, oncology and hematology strongly preferred. Scientific degree, e.g., PhD or equivalent is a plus.
Familiarity with and commitment to work in accordance with Federal Regulations, Good Clinical Practices, and ICH guidelines.
Willingness to take ownership of assignments and to proactively consult and follow up with other project team members and other department representatives for information or guidance, as necessary.
Appropriate mastery of English.
Ability to coordinate multidisciplinary teams.
Strong technical expertise in electronic document management and word processing and presentation software is required, e.g., MS Word, MS PowerPoint, and Adobe.
Ability to work independently, yet collaboratively with Program Leaders from multiple cross functional areas (i.e., Quality, Regulatory Affairs, Clinical, Research and Operations).
Able to communicate scientific and technical concepts, program objectives, data analysis within a matrixed organizational environment.
Excellent people management skills with the ability to partner and influence across the organization.
Working Conditions and Physical Requirements:
Travel may be required.
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.