TransPerfect 于 2020-09-23 发布了

summary
transperfect life sciences is seeking outstanding and diverse candidates to help our clients operate more effectively in the global marketplace. transperfect is looking for freelance medical writers with a sense of urgency, a passion for client service, and a desire to help the world's leading global firms conduct business more effectively.
freelance medical writers are responsible for providing scientific publications, clinical regulatory documentation, medical information pieces, and more.
the principal medical writer is responsible for providing scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. interfaces with external groups (e.g. pk, toxicology, esubmissions, regulatory, statistical support, data management, clinical, publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. serves as the scientific writing content expert for the department. as a successful candidate you will have an extreme sense of urgency and superior attention to detail.

responsibilities:
• serves as medical writing lead on complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers
• works closely with the publications or regulatory team(s) on document strategies. implements all activities related to the preparation of scientific publications
• converts relevant data and information into a form that meets clinical regulatory document requirements
• responsible for effective communication among team members and identifying and resolving conflicts to ensure teams achieve project goals
• understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and sops
• works with regulatory quality assurance throughout clinical regulatory document audit process and works with team to draft responses as necessary
• maintains expert knowledge of us and international regulations (maintain certifications)
• serves as a department representative on project teams
• acts as subject matter expert edocs, ectd, and journal/congress databases
• coaches, mentors, and assists medical writers
• recommends, leads, and implements tactical process improvements, both within the department and division-wide
• drafting of srls (including the pml safety update) – create/update srls as needed, formatting new content according to approved templates
• occasional international and domestic travel required for industry related conferences

about you:
as a principal medical writer, you are a:
• creative thinker – you are curious and unafraid to ask questions
• hard worker – you are industrious and diligent in everything you do
• innovator – you are willing to initiate changes and introduce new ideas

your experience includes:
• bachelor of degree from year university
• masters or phd in science discipline with relevant writing experience (preferred)
• american medical writing association (amwa) or international society for medical publication professionals (ismpp) certification preferred
• 4 years relevant industry experience in medical writing
• 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
• excellent written and oral communication skills
• advanced experience in word processing, flow diagrams, and spreadsheets.
• experience in working with collaborative, cross-functional teams