PRAHS

  • Principal Medical Writer

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(11/1/2018 8:51 AM)
    ID
    2018-50143
  • Overview

    The purpose of this job is to create, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, experienced medical writer with demonstrated leadership preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD who can guide others in these processes.

    As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers

    Responsibilities

    • Work independently with project teams to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development under strict timelines.
    • Provide leadership in completing major summary submission documents (e.g., pivotal study reports, Clinical Summary of Efficacy, Clinical Summary of Safety, Clinical Overview) to support high-quality submission dossiers.
    • Ensure a consistent style of presentation of clinical document to maintain quality and ease of review, and adhere to company standards.
    • Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
    • Contribute to Clinical Cluster, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate efficient development and submission of products.
    • Mentor more junior medical writers and provide leadership in completion of large writing projects in order to foster team development.
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    Major Challenges

    • Managing completion of high-quality documents on time when deliverables are late or of low quality or other team members are not performing adequately. Problem solved through leadership, negotiation, mentoring, and enlisting support of others.  

     

    Key Internal/External Relationships:

    • Members of Clinical Trial Teams, with whom a princiapl medical writer interacts daily. Members of Cluster, Project, and Submission teams from other groups within International Development, as needed, to plan and implement large projects.

     

    Decision Making Authority:

    • Decisions are made on the scientific and regulatory content and format of documents and steps needed to complete high quality documents according to timelines. Decisions are also made on timelines for document completion. Requests for resources and issues of document preparation strategy are referred to supervisor.

    Qualifications

    • Bachelors degree required (advanced degree preferred) plus Substantial experience (8-10 years) as a medical writer, or equivalent, and presenting relevant specialist qualifications (e.g., Ph.D. in life sciences).
    • Experience preparing clinical regulatory submission documents, including CTD Module 2 summaries. Accurate and detail-oriented with excellent inter-personal skills. Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Native English speaker or have proven excellent spoken and written English. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.
    • Familiarity with written and oral French or German languages. Specific knowledge of company-targeted therapeutic areas. Specific knowledge of clinical development of these therapeutic areas is strongly desirable, as is submission experience with biological agents.







    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

     To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.






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