Medical Writer

Location: Malvern, Pennsylvania
Posted On: 9/14/2017
Job Code: 4972_MW_PA
Job Description
Position Details:
Job title : Medical Writer
Location: 2 West Liberty Blvd. Suite 300 Malvern Pennsylvania USA 19355
Duration: 4 Months

Primary areas of responsibility:
With supervision and guidance from the medical writing manager or project leader;
• Writes clinical sections of IND/NDA annual reports accurately and in accordance with regulatory guidelines and departmental/editorial standards.
• Ensures that information included in the clinical sections of the IND/NDA annual reports are clear and concise and has received the necessary critical/scientific review.
• Advise departmental and other personnel, as required, regarding the organization and presentation of information and the design and formatting of data displays by serving as a resource for competence in writing and communication.
• Performs the necessary literature searches to support the authoring of IND/NDA annual reports and DSURs.
• Maintain appropriate records.

Supplemental areas of responsibility:
• Coordinates, schedules, and prepares the DSURs in accordance with regulatory guidelines and departmental and editorial standards, or provide other support in the preparation of the DSUR.
• Ensure that information included in the DSUR is clear and concise and has received the necessary critical/scientific review.
• Maintain appropriate records.
For all assigned documents and other projects, provide medical writing support and work effectively with project teams, as indicated by:
• ensuring adherence to editorial and regulatory house style standards and contributing to clarity and scientific content
• completing or assisting in the completion of high-quality regulatory documents accurately and on time, according to regulatory guidelines
• appropriately communicating and interacting with the project team (eg, attending/conducting meetings, teleconferences, etc)
• communicating effectively with the manager, medical writing on progress made and issues/problems raised

(1) communications, interpersonal, organizational, problem solving, and document preparation skills,
(2) competency in relevant software applications and using templates and electronic formats, (3) a knowledge of government regulations pertaining to drug development and the drug development process,
(4) the ability to manage writing projects and work under time constraints.
Category:IT  code:new
Job Requirements
SOX, Ms Access, EDI, Management, Focus, er, Purchasing, ERP, Procurement

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Contact Details
Ayushi Dixit
E-mail Address