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.

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 skillsin English

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

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