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 For more information on the TransPerfect Family of Companies, please visit our website at

📌 Senior Medical Writer | Spain (Barcelona)
🏢 Transperfect
📍 Barcelona