Medical Writer

Yoh has multiple opportunities for Medical Writers to assist our customer, a global pharmaceutical company, with many new projects.

This is an on-site contract assignment slated to last one year. Chosen candidates will be asked to complete a writing exercise prior to a phone interview.

Job Details:

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.

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

Minimum Requirements:

• Baccalaureate degree in biomedical discipline.
• 3-5 years of work experience is required

• 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.
• Regulatory Writing, Protocols, ISE, ISS, SCS, SCE, IPI, RMP, CSR, Clinical Overviews, Summary of Clinical Safety or Summary of Clinical Efficacy, and Clinical Study Reports.

Successful completion of a drug screen and a Federal/Criminal background investigation will also be required prior to employment.

Discover all that's possible with Yoh. Apply now.

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