Location: Pleasanton, CA
Requisiton Number: 484
# of openings: 1
The Director/Sr. Director, Medical Writing is a leadership role that includes advising on, developing,and writing clinical and nonclinical documents for NDA/MAA submissions, as well as other documents for regulatory submission and technical/scientific publications. This position builds strong working relationships with Clinical Development, Regulatory Affairs, Preclinical, Global Safety, external collaborators and Contract Research Organizations. The scope of documents ranges from pre-IND through NDA.
Provide broad medical writing and project management support for the programs and efforts of the Clinical
Development group. This is a hands-on position that entails writing and editing clinical documents for
submission to regulatory authorities.
• Provide interpretation and advice on regulatory guidelines (including NDA, MAA, and CTD) as they relate to
specific requirements for regulatory submission documents.
• Provide leadership within Medical Writing.
• Responsibilities include, but are not limited to: briefing documents, clinical development plans, previous
human experience summaries, human pharmacology summaries, investigator brochures, clinical study
protocols and amendments, model informed consents, orphan drug applications, pediatric plans, interim and
final clinical study reports, patient narratives, CTD clinical and nonclinical overviews and summaries, safety
updates, and integrated summaries of safety and efficacy.
• Author, co-author, update, and critically edit publications (manuscripts, review articles, abstracts, poster and
presentations, etc.) in support of company programs and products.
• Perform literature searches/reviews as necessary to obtain background information and training for
development of documents.
• Participate in electronic document publishing efforts. Initiate and manage development of formats, templates
and general guidelines for clinical documentation and workflow procedures. Ensures document content and
style adheres to ICH/FDA/EMEA or other appropriate regulatory guidelines and complies with departmental
and corporate or client SOPs and style guidelines.
• Assist in the development of departmental SOPs and guidelines.
• Facilitate internal review of materials or documents and consolidate comments from internal and external
reviewers or writers.
• Build consensus and implement, and continually improve cross-functional processes to ensure maximum
• Build strategic relationships within Astex and with business partners, vendors and key external though leaders
to help facilitate involvement with writing activities.