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Associate Director of Medical Writing

Trenton Metro Area, NJ

Post Date: 01/29/2018 Job ID: JN -012018-20820 Job Type: Scientific
  • The Associate Director, Medical Writing - Oversee clinical development programs. This role will both manage other clinical / medical writers and work directly on documents/projects with cross-functional teams.
  • Responsibilities:
  • Serving as the Medical Writing Lead
  • Ensuring that documents are appropriate while also meeting all regulatory requirements
  • Managing, leading, and/or assisting more junior writers and other medical writing-related staff (including contract or CRO staff)
  • Developing a comprehensive understanding of study designs, objectives, analyses plans, and results
  • Proof reading medical writing, oversight of vendor selection, contracting, and management
  • Building and maintaining collaborative relationships with medical writing partners (employees, CROs, and the medical writing community)
  • Performing document-specific tasks such as (a) Drafting or overseeing clinical study reports, (b) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells, (c) ensuring editorial review of documents (grammar, punctuation, and formatting), and (d) ensuring quality-checking of documents (including for submission-ready formatting)
  • Ensuring compliance with templates and standard operating procedures (SOPs) and applying the principle of continuous improvement to all in-house and contracted medical writing procedures
  • Contributing to clinical development team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
  • Providing training and guidance on medical writing best practices
  • Participating in departmental oversight, including projection of annual budget and resource needs
  • Requirements: Advanced degree and 5 - 8 years of experience in pharmaceutical, CRO or related clinical research as a medical writer and leader.
  • Experience across most types of regulatory medical writing deliverables
  • Must be able to plan activities of self and others, and manage the deliverables of others in accordance with pre-established timelines, while systematically performing activities in a timely and accurate manner
  • Demonstrated ability to independently make and execute strategic decisions, based on quickly digesting and assimilating pertinent information, and including leading cross-functional teams through execution
  • Demonstrated ability totranslate technical information from mixed sources into written information suitable for an audience of clinicians and regulatory authorities while summarizing data that enables reaching conclusions and exercising judgment to move projects forward
  • Training in the biomedical sciences, as well as experience in technical written communication and working cross-functionally, including with partner companies and vendors
  • Advanced writing and speaking competency

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