Manager Medical Writer

Employer
ICON Clinical Research
Location
Raleigh, North Carolina
Salary
Not a constraint
Closing date
10 Oct 2020

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
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Medical Writing Manager (ICON Medical Imaging) JR066540 


• Supervises and provides general assistance to the Imaging Medical Writing Team. 
• Organizes and maintains the medical writing work schedule. 
• Assigns suitably experienced Medical Writers to projects. 
• Liaises with Clinical Project Managers with regard to the availability of medical
writing resources and the establishment of project timelines. 
• Writes and reviews documents prepared by the Medical Writers including studyspecific documents such as Independent Review Charters (IRC),

Site Imaging Manuals (SIM) and Independent Review Training Manuals (IRTM).

• Understands key reading criteria such as RECIST, mRECIST, Choi, RANO, Cheson,
Lugano Classification, Halleck, iRECIST, RECIL, iRANO/bmRANO/pedRANO,
PCWG, and PCWG3. 
• Knowledge of current industry regulations and standards. 
• Keeps the medical writing senior management informed, when required, of the status
of medical writing projects and, in particular, any issues that affect document quality. 
• Collaborates with imaging department heads and project teams to prioritize
deliverables and support project scope of work. 
• Manages the administrative requirements of the department. 
• Prepares monthly metrics reports and presents to senior management. 
• Provides input to Standard Operating Procedures and Work Instruction documents as
necessary. 
• Ensures correct conduct of ongoing projects and effective representation of the
department's capabilities for potential projects. 
• Ensures that sponsor projects are implemented and conducted in accordance with

ICON’s requirements. 


• Assesses and maintains the quality of department deliverables. 
• Provides new business cost estimates when required and supports Business
Development in new business acquisitions for medical writing projects. 
Qualifications: 
• Bachelor's or Master’s degree in Life Sciences/Health Related Sciences or equivalent
required. 
• Medical/technical writing experience of 7+ years in a clinical research setting. 
• Experience in a managerial or lead role, including project/resource allocation
experience. People management experience is preferred. 
• Demonstrated understanding of clinical research, the drug development process, and
applicable regulatory guidelines. 
• Able to work independently. 
• Attention to detail and ability to multitask. 

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceuticalbiotechnologymedical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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