Medical Writer Consultant

Location: Malvern, Pennsylvania
Posted On: 9/14/2017
Job Code: MW_PA_3255
Job Description
Client : Pharmaceutical
Work Location : Malvern PA 19355
Job Title :Medical Writer Consultant
Duration : 4 Months (possibilities of extension - Full time contract)

The contract writer will plan and write and/or edit regulatory documents. The writer will ensure documents adhere to applicable regulatory guidelines and departmental/editorial standards. The position will primarily focus on IND/NDA annual reports but may include authoring or supporting Developmental Safety Update Reports (DSURs) as well. Further responsibilities will involve performing literature searches for IND/NDA/DSURs and other tasks as needed.

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.

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 (e.g, attending/conducting meetings, teleconferences, etc)
communicating effectively with the manager, medical writing on progress made and issues/problems raised

Minimum qualifications:
This position requires:
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, Purchasing, ERP, Procurement

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Contact Details
Vishnu Krishnan