Medical Writer at TransPerfect

About the job

• The 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.).
• The 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. 
• The 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.

RESPONSIBILITIES

• Provide 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
• Direct 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
• Proactive 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
• Responsible for effective communication among team members and identifying and resolving conflicts to ensure teams achieve project goals
• Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs
• Quality-checking documents for agreement between in-text information and the source data, and for internal consistency
• Maintain knowledge of US, EU, and other international regulations (gains and maintains certifications)
• Act as Subject Matter Expert in eDocs, eCTD
• Development, implementation, and maintenance of operations related to sponsor’s clinical trial results disclosure throughout each product’s development lifecycle
• Recommend tactical process improvements, both within the department and division-wide
• Occasional international and domestic travel required for industry-related conferences
• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

REQUIRED SKILLS, EXPERIENCE AND QUALIFICATIONS

• Masters or PhD in science discipline Preferred – American Medical Writing Association (AMWA), European
• Medical Writing Association (EMWA), or International Society for Medical Publication Professionals (ISMPP)
• certification
• Thorough understanding of ICH, GLP, GCP, GMP, and style guide standard compliance
• 3-5 years of relevant industry experience in medical writing
• Creative thinker – Curious and unafraid to ask questions
• Hard worker – Industrious and diligent in everything you do
• Innovator – Willing to initiate changes and introduce new ideas
• Client-facing
• Excellent written and oral communication skills
• Extensive knowledge of English grammar and spelling, as well as medical terminology

DESIRED SKILLS, EXPERIENCE AND QUALIFICATIONS

• Experience writing high-level content for clinical publications or clinical regulatory documents
• Experience in assimilation and interpretation of scientific content
• Working knowledge of statistical concepts and techniques
• Advanced experience in word processing, flow diagrams, and spreadsheets
• Experience in working with collaborative, cross-functional teams
• Proficiency in Word, PowerPoint, Excel, Outlook, and scientific databases including PubMed, Embase, etc.