Senior Medical Writer

We’re seekingan organized, motivated, and collaborative individual for our medical writing team. Theseniormedical writer will partner cross-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management inleading theplanning and preparation of high-quality clinical regulatory documents. The medical writer may produceprotocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines. Location: Fully remote in the US, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients asrequested. Responsibilities

Lead theexecution of documents, includingproject management tasks such ascreating,maintaining, and communicatingtimelines Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)to ensuretimelycompletion ofdocuments Ensuredocument developmentadherestoanyrelevantclient processes, templates, and instructionaldocuments Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient documentdevelopment Lead document message development in collaboration withclient Interpret data and create shell documents to supportauthoring Plan and lead kickoffmeetings Facilitate resolution of review feedback including planningand leadingcomment resolution meetings(curate review comments to ensuremeetings areefficient) Follow-up with individual team members asneeded to resolve outstanding reviewfeedback Ensure consistency among client programs in terms of messaging, formatting, and presentation ofdocuments Conduct literature searches asneeded Perform peer QC review asneeded

Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed

Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field Bachelor’s degreeor higherin a relevant field Oncology, InfectiousDisease, or Vaccineexperiencedesired Experiencedesiredin writingclinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5documents Flexibility towork across multiple therapeutic areas, if needed Experiencewriting documents according toestablished processes and documenttemplates Familiarity with lean authoring approachesand structured content management Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements isdesired Expertisewith Microsoft Word and other Microsoft applications Experiencedeveloping documentsusingdocument management systems, collaborative authoringtools, and reviewtools Comfortableadaptingto newtools andtechnologies, if needed Ability to work both independently and collaboratively in the face of competingpriorities Service-oriented and proactive approach to projectmanagement Excellent conflict management and negotiation skills Comfortable providing suggestions based onpreviousexperience Strong written and verbal communication skills

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law For more information on the TransPerfect Family of Companies, please visit our website at #J-18808-Ljbffr