Medical Writers

THESE JOBS HAVE BEEN POSTED FOR AWHILE BUT THOUGHT I WOULD MENTION                  THEM AS IT'S A NEW SITE I CAME ACROSS.

 

Regulatory Writers                           (posted 6/11/2013)

(independent contractor / freelance)

 

Multinational pharmaceutical company is seeking highly experienced remote-based freelance regulatory writers (senior medical writer level or higher) to develop clinical study reports and eCTD clinical summary documents (US/EU/rest of world). 

 

Required skills and experience:

Must have excellent written and verbal communication skills

Experience with electronic document management systems

Ability to work well with cross-functional teams. 

Self-motivated

Organized and attentive to details

College degree in a scientific or medical discipline or equivalent (advanced degree is desirable), with a minimum of 5 years of relevant medical writing experience. 

 

Interested candidates will be asked to complete a writing test.  Please send CV and letter of interest detailing document experience and therapeutic area expertise to dana.johnson5480@gmail.com

Regulatory Medical Writer          Posted 5/12/2013
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers.
 
Position Summary:
We currently have a great contract opportunity for a Regulatory Medical Writer with extensive Phase I writing experience.  This is a long-term contract position that is home-based and requires work to be done within standard business hours, Monday-Friday.
The Medical Writer researches, prepares and coordinates scientific publications: this includes writing and editing clinical/statistical reports and study protocols and summarizing data from clinical studies for submission to the Food and Drug Administration (FDA).

Requirements:

• Bachelor’s degree in a scientific discipline or licensed certification as RN or other healthcare discipline equivalent professional experience.
• Five or more years of relevant writing experience within the CRO industry.
• Ability to manage large writing projects with minimal supervision.
• High degree of independence in decision making and problem solving.
• Ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing.
• All requisite skills of the Medical Writer position, including excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data.
• Extensive Phase I medical writing experience.
• Experience with a large volume CSRs.
• Oncology experience.

Job Responsibilities (other duties may be assigned):

• Interact with sponsor to determine format, design, and direction of complex Medical Writing deliverables.
• Design tables and figures for presentation of data.
• Review information with the Project Manager and Biostatistician to define patient populations for analysis.
• Interpret statistical data to develop text.
• Prepare deliverables.
• Identify and coordinate meetings with in house reviews to define needed revisions.
• Represent Medical Writing on project teams and update Medical Writing management on the status of projects.
• Act as project manager for specific projects, including budgeting, allocation of resources, timelines, billing approval, contract negotiation, and sponsor contact.
• May direct the activity of a team of writers.
• Budget and forecast project-related costs and sets timelines for completion of projects.
• Track budget and timelines for projects.
• Prepare time and cost estimates for future projects and interact with Bids and Contracts to prepare proposals for writing projects.
• May design templates for deliverables.
• Act as a liaison on interdepartmental projects.
• Advise Medical Writing management on the development of new processes, WPD and SOP.
• Research current literature to design clinical studies.
• Write complex study protocols with reference to current research and FDA guidelines.
• Act as a mentor for other Medical Writers.
• Participate in internal and external training as appropriate regarding guidelines and requirements of the FDA and other regulatory agencies.
• Prepare materials and give marketing presentations to potential clients on the capabilities of the Medical Writing Group.

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