Medical Writer/Disclosure Specialist

Global pharmaceutical company is seeking an experienced Medical Writer to join their Clinical Documentation Team as a Disclosure Specialist in either their NJ or MA office. The writer's primary function will be to manage public disclosure of clinical trial protocol information and results for clinical studies in line with regulatory requirements and company public disclosure strategy. This position has WORK FROM HOME FLEXIBILITY!

Responsibilities:

- Prepare the scientific content to be posted on intranet websites based on clinical documentation (ie., protocols, clinical study reports, etc.)
- Interact closely with the clinical/statistical study team as well as with other key functional teams
- Disclose results in ICH E3 summary; format statistical figures to be entered in the ClinicalTrials.gov registration system
- Ensure consistency of the information to be posted with already publicly disclosed information as well as with information submitted to Regulatory Authorities.

Skills/Requirements:

- Minimum 3 years of regulatory writing experience (authoring CSR's, IB's, protocols, etc.)
- B.S, M.A., or equivalent professional experience
- Experience in biostatistics or regulatory affairs is a plus
- Knowledge of the disclosure environment, regulations, and website
- Thorough knowledge of the clinical process
- Attentive to detail, organized, great communication skills, good team player

Don't miss out on the opportunity to join a great team at a stable company with a huge portfolio with WORK FROM HOME FLEXIBILITY! Apply today and send resumes to Jess Lakis at Real Staffing (tel: 212-707-8499).
To find out more about Real please visit www.realstaffing.com