Medical Writing 20308-MZ
Job Title: Medical Writer
The Contract Medical Writer authors, edits and provides high-quality clinical documents from planning and coordination through delivery of final drafts for regulatory fulfillment of assigned therapeutic areas and/or products in Clinical Development to US and other global health authorities using appropriate processes, tools and technology.
The incumbent works cross-functionally with internal departments and external resources on Medical Writing related issues.
The Contract Medical Writer collaborates on the development of clinical documents in accordance with all applicable regulations to Good Clinical Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association (EMA) Clinical Trials Directives, International Congress on Harmonisation (ICH) guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.
*Prepares complex clinical documents that present clinical data objectively and in a clear, concise format. This includes, but may not be limited to: protocols and amendments, Clinical Study Reports (CSRs), Investigator Brochures (IBs), briefing books, response to authorities, etc.
*Prepares regulatory documents including, but not limited to, Common Technical Document (CTD) Module 2 and Module.
Collaborates with pre-clinical Subject Matter Experts (SMEs) to incorporate pre-clinical data into clinical and regulatory documents
*Writes and edits abstracts, manuscripts, posters, and presentations for scientific meetings and manuscripts for publication in scientific journals; coordinates the processes involved in submitting such documents to scientific meetings and journals.
*Contributes to development and implementation of medical writing processes, templates, and style guides.
*Performs other tasks and assignments as needed and specified by management.
Advanced degree (PhD or PharmD) a minimum of 5 years of medical writing experience in pharmaceutical, biotechnology, contract research organization or related environment/industry OR a Bachelor's degree in a scientific discipline and a minimum of 8 years of medical writing experience in a pharmaceutical, biotechnology, contract research organization (CRO).
Special knowledge or skills needed
*Demonstrated experience writing, editing, and formatting documents having scientific/medical content and requiring knowledge of Food and Drug Administration (FDA) guidance and EMA/ICH guidelines pertaining to the specific types of documents.
*Experience in writing clinical protocols and amendments, CSRs, IBs, briefing books, responses to health authorities, and regulatory submission documents.
*Demonstrated ability to critically analyze and to clearly, accurately, and concisely prepare all clinical regulatory documentation, including major submission and/or complex documents in English.
*Excellent understanding of biostatistics reporting standards and awareness of the associated biostatistics concepts.
*Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure.
*Proficiency with Microsoft Office and use of electronic document templates.
*Excellent verbal and written communication skills.
*Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
*Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
*Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects simultaneously, while maintaining priorities and high quality results.
Special knowledge or skills preferred
*Ability to plan, write, review, and edit a variety of clinical and scientific regulatory documents and ensure that these documents adhere to applicable regulatory guidelines and standards.
*Experience with IND and NDA/MAA submissions.
*Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines.
*Broad knowledge of FDA and EMA/ICH guidelines guidance beyond those pertaining to specific regulatory documents.
*Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools.
*Proficiency in Adobe Acrobat and Electronic Common Technical Document (eCTD) templates.
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