• tech observer
  • $37,710.00 -59,190.00/year*
  • Woodcliff Lake, NJ
  • Non-Executive Management
  • Full-Time
  • 8 Dorchester Rd

This is a DIRECT HIRE Opportunity for Senior Manager of Medical Writing located in Woodcliff Lake, NJ

Description:
The Senior Manager, Medical Writing will be the designated Lead Medical Writer. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.
- Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead
- Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material
- Routinely engaging clinical research and biostatistics to gain comprehensive understanding of study design, objectives and results
- Providing guidance to other medical writers applying industry and medical writing best practices
- With minimal supervision, preparing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
- Contributing to the writing of marketing application submission documents
- At the Director's discretion, may provide work direction to contractors/consultants
- Contributing to process improvement within and across functional areas
- Influencing medical writing strategies and processes within and across functional areas
- Monitoring and evaluating project metrics, escalating issues as needed

Job Qualifications:
- Bachelor's Degree required; an advanced degree is preferred.
- Minimum of 5 years' medical writing experience in CNS, with specific experience with compounds targeted for epilepsy preferred
- Able to work on site
- Advanced working knowledge of MS project and MS Word
- Experienced in the use of a document management system

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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