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          Director/Senior Director, Medical Writing

          Astex Pharmaceuticals
          Pleasanton, CA 94566
          Full-time, Part-time
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          Job Description

          Director/Senior Director, Medical Writing

          Location: Pleasanton, CA

          Requisiton Number: 484

          # of openings: 1

          Description

          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. 

          Responsibilities:

          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
          efficiency.
          • Build strategic relationships within Astex and with business partners, vendors and key external though leaders
          to help facilitate involvement with writing activities.

          Qualifications:

          • Education and experience: Bachelor's degree in chemistry, analytical chemistry, or pharmaceutical relevant field + 10 years relevant experience in the pharmaceutical / analytical R&D environment; Master's degree + 7 years; or Ph.D. with 5+ years.
          • Experience with preparation of drug substance and drug product sections of regulatory filing documents
          • Thorough knowledge of chemistry and expertise with analytical methodologies for the testing of small molecules
          • Hands-on experience with analytical methods for the testing of small molecules such as HPLC/UPLC, LC-MS, dissolution, Karl Fischer titration, and GC.
          • Superior communication skills for interactions with technical personnel at Astex and contract facilities, cross-cultural team skills
          • In-depth understanding of ICH, compendial, FDA, cGMP, and CMC guidelines and requirements and industry best practices
          • Familiarity with drug development process, both drug substance and drug product
          • Potential to manage junior analytical staff
          Posting ID: 566866888Posted: 2020-08-08