Senior Medical Writer

Job Description

Synterex, Inc. is aglobalconsortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support.

Synterexoffers remote or on-site services, with a focus on providing clear, concise,accurate, and fully compliant documentation, from early drug development through post-approval.

Synterexisseekingan organized, motivated, and collaborative individual for our medical writing team.

Theseniormedical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management inleading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines.

Location:

Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.

• Lead the execution of documents, including project management tasks such as creating,maintaining, and communicating timelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensuretimelycompletion of documents
• Ensure document developmentadherestoanyrelevantclient processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development
• Lead document message development in collaboration with client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback including planning and leading comment resolution meetings(curate review comments to ensure meetings are efficient)
• Follow-up with individual team members asneeded to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• 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, Infectious Disease, or Vaccineexperiencedesired
• Experiencedesiredin writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5documents
• Flexibility towork across multiple therapeutic areas, if needed
• Experiencewriting documents according to established processes and document templates
• Familiarity with lean authoring approaches and 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
• Expertise with Microsoft Word and other Microsoft applications
• Experience developing documentsusingdocument management systems, collaborative authoring tools, and review tools
• Comfortableadaptingto newtools and technologies, if needed
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based onpreviousexperience
• Strong written and verbal communication skills

Synterexprovides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal,stateor local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence,compensation and training.

Synterexparticipates in the Department of Defense’sSkill

Bridge program. For more information, please visit