Medical Writer Resume Rockville, MD - Hire IT People

Objective

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Medical Writer

Confidential, Rockville, MD

Responsibilities:

Review clinical research data, published technical reports, pharmaceutical manufacturing data/reports, and technical reports as needed to prepare regulatory documents required for evaluation of clinical research studies conducted under the FDA.
Write/rewrite and edit original technical documents based on scientific literature and clinical data.
Access and update clinical and regulatory databases as needed to support review and writing of regulatory documents.
Communicate/discuss technical/regulatory issues with Government, clinical, QA (Quality Assurance) production, and subcontract personnel as necessary to develop technical and regulatory documents.
Supervise scheduling and execution of task assignments and help maintain the Task Table.

Sr. Site Support Specialist

Confidential, Columbia, MD

Responsibilities:

Review and assist IRB with approval/disapproval of new principal investigators.
Communicating to Sponsors and sites of IRB actions and issues that the board has put forth for the study and/or site.
Creating approval documents for approved principal investigators.
Advising principal investigators on human research protection regulations.
Assisting principal investigators maintain compliance to federal regulations regarding human protection in research.
Assisting coordinators on study related changes, specifically related to the Informed Consent Forms.

Site Support Specialist

Confidential, Columbia, MD

Responsibilities:

Review and assist IRB with approval/disapproval of new principal investigators.
Clarifying issues presented by the IRB review.
Creating approval documents for approved principal investigators.
Assisting principal investigators with Informed Consent Modifications.
Review and assist IRB with approval/disapproval of study specific recruitment material.
Advising principal investigators on human research protection.
Audit and Acknowledging CV’s, Licenses, FDA Form 1572’s and any other material submitted to the IRB.

Content Developer and HTML Coder/ Help Desk Team Member

Confidential, Columbia, MD

Responsibilities:

Developed addendum to policies to determine the affect of state laws in regard to HIPAA.
Developed training, gap assessment and policies for OIG compliance for Billing Companies.
Developed training, gap assessment and policies for OIG compliance for Small Group Physicians.
Re - wrote policies to reflect changes that occurred to HIPAA security.
Assisted in developing a risk assessment tool for healthcare providers.
Coded (html format) training, gap assessment and policies into questionnaires and templates.
Answered first-level HIPAA related questions as appropriate from healthcare providers.

Publishing Assistant

Confidential, Columbia, MD

Responsibilities:

Assisted Chief Content Officer in developing and formatting material on HIPAA Privacy Rule - published as a book by the Texas-based Privacy Council.
Maintained files and versions of all manuscript contents.
Maintained correspondence with all sections authors.
Performed editorial updates under supervision.