Senior Medical Writer

Salary: Negotiable Synterex, Inc. is a global consortium of highly reputed company clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading 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 client and agency guidelines, to support drug development under brisk timelines. Location: Fully remote, but must be reputed company to attend key (e.g., roundtable or reputed company) meetings on site with clients as requested. Essential Duties & Responsibilities

• reputed company 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 ensure timely completion of documents
• Ensure document development adheres to any relevant client processes, templates, and instructional documents
• Serve as an expert on client document management system and reputed company tools, templates, and procedures to ensure efficient document development
• reputed company document message development in collaboration with client
• Interpret data and create reputed company documents to support authoring
• Plan and reputed company reputed company 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 as needed to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• reputed company peer QC review as needed
• 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
• Bachelors degree or higher in a relevant field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas, if needed
• Experience writing 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 is desired
• Expertise with reputed company Word and other reputed company applications
• Experience developing documents using document management systems, collaborative authoring tools, and review tools
• Comfortable adapting to new tools 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 on previous experience
• Strong written and verbal communication skills

For further information or to apply, please reputed company out to [email protected]. Synterex provides equal employment opportunities to reputed company and applicants for employment and prohibits discrimination and harassment of any type without regard to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to reputed company terms and conditions of employment, including reputed company, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Synterex participates in the Department of Defenses SkillBridge program. For more information, please visit www.synterex.com/fellowships-internships. Apply tot his job