Senior Medical Writer

TransPerfect; United States; Remoto; USD 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

TransPerfect is seeking an organized, motivated senior medical writer to join our medical writing team in the United States. This role partners cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents.

The senior writer will produce protocols, publications, study reports, investigator brochures, narratives, and module documents in line with client and agency guidelines to support

Competenze

• 5+ years experience as a medical writer in CRO/biotech/pharma.
• Strong ability to manage documents and templates.
• Experience writing protocols, study reports, and regulatory documents.

Mansioni

• Lead the execution of documents and project timelines.
• Coordinate cross-functional contributors and internal resources to ensure timely completion.
• Ensure adherence to client processes, templates, and instructions.
• Serve as an expert on the client document management system and tools.
• Lead document message development in collaboration with the client.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings.
• Facilitate review feedback and resolve comments.
• Maintain consistency across programs in messaging and formatting.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives if needed.

Conoscenze

Medical writing

Project management

Cross-functional collaboration

Communication skills

Formazione

Bachelor’s degree or higher in a relevant field

Strumenti

Microsoft Word

Document management systems

Publishing tools

Descrizione del lavoro

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

Requirements:

• 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 www.transperfect.com.