Medical Communications ScientistPosted: November 13, 2009
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration and to sustain competitive products in the US.
Major Responsibilities:
- Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
- Critically assesses, interprets, and accurately summarizes medical data.
- Contributes to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
- Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers.
- Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
- Interprets and monitors current and emerging communication issues and guidelines.
- Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Degree / College Major: Science background (eg, MS/PhD)
Number of Years Work Experience Required: 3-5 years
Minimum Requirements:
- Baccalaureate degree in biomedical discipline.
- Knowledge of the drug development process and human pathophysiology and diseases.
- Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly.
- Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management.
- Knowledge of regulatory requirements and guidelines and standards.
- Influencing, interpersonal skills.
- Ability to travel nationally and internationally
Preferred Background.
- Advanced biomedical degree.
- Budget and resource management skills.
- Knowledge of competitors and competitor products.
- Editor in Life Sciences (ELS) certification. Please refer to job code mcs101409 when responding to this ad.
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