Description
Position Summary:I'm seeking a Senior Manager, Medical Writing who is a skilled facilitator that desires an opportunity to work as a medical/scientific expert. This position requires a high?functioning medical writer who wants to do more than author documents. It is an opportunity for the successful individual to be a champion for medical writing and to work closely with cross-functional clinical/development teams to drive document preparation, and ensure that each document's key messages are accurately shared, evaluated and presented.
Key Responsibilities:
- Manages all aspects of the medical writing processes for document development from start to finish including: scheduling, tracking and driving document preparation, review, and approval.
- Supervises and ensures quality and consistency of work performed by external medical writers.
- Collaborates with project physicians, statisticians, programmers, regulatory personnel, and commercial personnel to facilitate effective interactions and information exchange among document co-authors and reviewers.
- Functions as a key medical writing contributor for clinical development teams to ensure that key messages and concepts are developed and incorporated into relevant documents.
- Contributes to the development of standard processes (eg, SOPs, templates, shells, etc) relating to medical writing.
- Writes, reviews and edits regulatory documents (eg, IBs, protocols and their amendments, CSRs, various Module 2 documents in CTD format, etc) in accordance with FDA and ICH guidelines and regulations as well as internal standards and processes.
- Develops regulatory documents within agreed timelines that have high-quality scientific content, organization, clarity, accuracy, format, and consistency.
Minimum Basic Qualifications:
- Bachelor's degree (preferably in a scientific or medical discipline)
- Strong background in science.
- Minimum of 12 years' experience as a medical writer working in the pharmaceutical/medical industry.
- Experience in regulatory submissions, including functioning as a medical writing lead for a regulatory submission.
- Expert level of proficiency with MS Office products and other applicable software programs.
Preferred Qualifications and Experience:
- Advanced scientific degree (eg.,MS, PhD, PharmD, MD)
- Knowledge of the anti-infective therapeutic area
- Demonstrated ability to work in matrix team environment
- Knowledge of electronic document management system
- Professional credentials in medical writing
- Excellent medical writing skills with the ability to analyze and interpret clinical and scientific data and to summarize findings in an objective and concise manner.
- Strong organization, time management, and detail-oriented skills needed to work in a stressful environment under tight deadlines while maintaining focus on quality.
- Ability to work well with colleagues in a professional office environment.
- Knowledge of FDA and ICH guidelines.
- Excellent project management skills.
- Excellent communication skills.
- Experience in contributing to and project management of global submissions.
Competencies:
- Demonstrates the ability to communicate clearly, concisely, and effectively to express information in both written and oral context
- Aptitude to compile, analyze, and present data in a concise manner
- Proven capability to focus on delivering excellent results and continually improve performance
- Capability to work on multiple projects and meet deliverable timelines
- Proven ability to drive issues to closure and demonstrate an effectiveness to work co-operatively with others in a team environment