Canadian Telecommuting

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Friday, June 28, 2013

Medical Writers

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. 
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

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).

  • 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.
For immediate consideration, click the Apply Now! button.


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