Medical Writers
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.
- 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.