About the job<\/p>\n
\tThe Regulatory Medical Writer collaborates with the Medical Writing team and clients to prepare high-quality regulatory documents (Investigators Brochures, Safety Narratives, protocols, investigator brochures, synopses, etc.).
\n\tThe Regulatory Medical Writer is responsible for providing clinical regulatory document support and scientific writing expertise to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process. The Regulatory Medical Writer will also be responsible for the expanded development, implementation, and maintenance of operations related to clinical trial registration and results disclosure.\u00a0
\n\tThe Regulatory Medical Writer will ensure effective and clear communication of technical information in scientific regulatory documentation writing. The role provides medical writing expertise for multiple compounds and\/or projects within a therapeutic area, and interfaces with external groups (e.g. PK, Toxicology, e-Submissions, Regulatory, Statistical Support, Data Management) and client teams to ensure accurate and timely completion\/delivery of information and review of clinical regulatory documents.<\/p>\n
RESPONSIBILITIES<\/p>\n
\tProvide overall medical writing support for ongoing projects. Preparation of clinical study-related documents, such as protocols, protocol amendments, clinical study reports, or other regulatory documents supporting ongoing clinical development programs
\n\tDirect performance of authoring for clinical trial results disclosure on ClinicalTrials.gov, EudraCT, ENCEPP, or similar platforms, including initial drafting, collaborative review and revision, quality control activities, approval, and release\/publication for public disclosure
\n\tProactive management of project timelines, ensuring that all relevant timelines are communicated, working cross-functionally, meeting required deadlines, maintenance of document archives, and updating project tracking systems
\n\tResponsible for effective communication among team members and identifying and resolving conflicts to ensure teams achieve project goals
\n\tUnderstand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs
\n\tQuality-checking documents for agreement between in-text information and the source data, and for internal consistency
\n\tMaintain knowledge of US, EU, and other international regulations (gains and maintains certifications)
\n\tAct as Subject Matter Expert in eDocs, eCTD
\n\tDevelopment, implementation, and maintenance of operations related to sponsor\u2019s clinical trial results disclosure throughout each product\u2019s development lifecycle
\n\tRecommend tactical process improvements, both within the department and division-wide
\n\tOccasional international and domestic travel required for industry-related conferences
\n\tComplete all other tasks that are deemed appropriate for this role and assigned by the manager\/supervisor<\/p>\n
REQUIRED SKILLS, EXPERIENCE AND QUALIFICATIONS<\/p>\n
\tMasters or PhD in science discipline Preferred \u2013 American Medical Writing Association (AMWA), European
\n\tMedical Writing Association (EMWA), or International Society for Medical Publication Professionals (ISMPP)
\n\tcertification
\n\tThorough understanding of ICH, GLP, GCP, GMP, and style guide standard compliance
\n\t3-5 years of relevant industry experience in medical writing
\n\tCreative thinker \u2013 Curious and unafraid to ask questions
\n\tHard worker \u2013 Industrious and diligent in everything you do
\n\tInnovator \u2013 Willing to initiate changes and introduce new ideas
\n\tClient-facing
\n\tExcellent written and oral communication skills
\n\tExtensive knowledge of English grammar and spelling, as well as medical terminology<\/p>\n
DESIRED SKILLS, EXPERIENCE AND QUALIFICATIONS<\/p>\n
\tExperience writing high-level content for clinical publications or clinical regulatory documents
\n\tExperience in assimilation and interpretation of scientific content
\n\tWorking knowledge of statistical concepts and techniques
\n\tAdvanced experience in word processing, flow diagrams, and spreadsheets
\n\tExperience in working with collaborative, cross-functional teams
\n\tProficiency in Word, PowerPoint, Excel, Outlook, and scientific databases including PubMed, Embase, etc.<\/p>\n
Apply via company website ( www.transperfect.com ) or<\/p>\n
www.linkedin.com<\/p>\n
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