Lead Medical Writer - San Diego, CA | Biospace
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Lead Medical Writer

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
4/20/2017
Position Type:
Full time
Job Code:
17-009 #798636
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

DNS is seeking an experienced, motivated individual to serve as the designated Lead Medical/Scientific Writer for all of our drug development programs. As a key contributor to the progression of multiple concurrent drug development projects, the successful candidate will work closely with cross-functional colleagues/multidisciplinary teams to ensure the timely completion of, accuracy of and quality of all clinical and regulatory submission documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will exhibit flexibility in moving across development and preparation of multiple document types. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.

Responsibilities include but are not limited to:

• Preparation of protocol synopses, protocols, and protocol amendments
• Ensuring and coordinating document quality checks for accuracy, collating reviewers comments, adjusting content of document as required based on internal/external input, and preparation of final version
• Routine engagement with the clinical research scientists and biostatisticians to gain comprehensive understanding of study design, objectives and results
• Preparation of all sections of the CSRs, including narratives, working across functional areas as needed to obtain all applicable source material
• Familiarity with relevant document templates (e.g., NIH-FDA clinical trial protocol template) and documents writing guidelines (e.g., FDA/ICH Structure and Content of CSRs)
• Working closely with statisticians to prepare statistical analysis plans
• Providing guidance to colleagues regarding industry and medical writing best practices
• Coordinating, and contributing to, preparation of Clinical Investigator’s Brochures
• Preparing clinical sections of regulatory documents (e.g., clinical trial applications, annual reports, briefing books, marketing applications)
• Maintaining and enhancing therapeutic area working knowledge, including disease state and compound, for assigned projects
• Maintaining and enhancing working knowledge of regulatory guidelines and publication guidelines.
• Assisting functional department heads in writing/finalizing SOPs as needed
• Providing management with appropriate information to ensure procurement of adequate and timely resources to complete medical writing deliverables
• At the Director's discretion, providing work direction to contractors/consultants
• Supporting Clinical and Regulatory department heads with scientific data disclosure planning
• Contributing to process improvement within and across functional areas
• Influencing medical writing strategies and processes within and across functional areas
• Working with teams to develop project specific metrics compliant with standard project metrics; influencing or negotiating change of timelines and content with other team members as needed
• Monitoring and evaluating project metrics, escalating issues as needed

Requirements

• Minimum of 5 years' Pharmaceutical Industry/CRO medical writing experience
• Specific writing experience supporting programs targeting neurologic/psychiatric disorders preferred, as is writing experience supporting early phase clinical development (i.e., Phase 1-2b)
• Recognized for technical expertise in specific document development
• Ability to effectively collect and evaluate information from multiple sources
• Excellent, high-level, end-user computer skills (e.g., word processing, tables, graphics, spreadsheets, presentation and templates) and software skills
• Thorough working knowledge/understanding of clinical trial design, methodology and statistical concepts
• Working knowledge of the IND/NDA process
• Excellent written and verbal communication skills as well as proven ability to interact with different functional groups
• Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields
• Good organizational, time management and interpersonal skills
• Strong ‘Customer Focus’
• Bachelor's degree required; an advanced degree in a scientific or health-related discipline is preferred.
• Self-motivated with the ability to influence others
• Ability to multitask
• Result driven with the ability to demonstrate time management and project planning
• Able to work on site and must be legally authorized to be employed in the United States.
• Participate in/coordinate preparation of scientific publications (i.e., planning, writing, editing, reviewing and finalization), including and not limited to, abstracts, posters, manuscripts and presentations) as needed
• Experienced in the use of a document management system