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1 October 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 25 |
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Inside the Insider |
Manager of Medical Writing; Midwestern US
Senior Medical Writer, Regulatory; Home Based |
Open Jobs and Gigs for Medical Writers | The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.
Because of the tough job market, the Insider now lists open jobs worldwide that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples include biostatistician, director of clinical research, and other clinical research titles. If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at [email protected]. We'd be delighted to publish such positions in the next issue of the Insider. |
Manager of Medical Writing Midwestern US |
Job Description:
A highly respected Midwestern CRO with 30+ years of success is growing their Medical Writing department and seeks an extremely well rounded in house Manager/Director to build a department and interface with national clients. Experienced candidates must have a PhD, hands-on experience writing highly complex regulatory submission documents, and experience managing a small staff. Those with strong leadership, scientific, clinical, and strategic skills are sought to work independently and collaboratively with a dynamic team. The hiring manager is committed to providing growth in other areas of the department as well. Compensation: $140-180K and relocation Qualifications: Minimum: 8 years of medical writing experience within a CRO, biotech, device or pharma. Must have PhD and 3 years of managing people.
E-mail your CV/resume Kathryn Crone, Smith Hanley Associates, at [email protected], or call 212-915-0500. |
Senior Medical Writer, Regulatory Home Based |
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations.
As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.
We are currently seeking a home -or- i3 office-based Senior Medical Writer, Regulatory.
The Senior Medical Writer, Regulatory, is responsible for developing, writing and editing clinical documents associated for use in regulatory activities.
Developing clinical regulatory documents including CSRs, protocols and investigator brochures using client or i3 Statprobe templates
Developing tables, charts, figures and other display elements for clinical data
Complying with client or i3 Statprobe procedures for completing deliverables, obtaining reviews, incorporating edits and working with teams to finalize deliverables
Managing medical writing activities associated with individual studies and across departments, keeping management and team members informed of project status
Actively participating in team meetings; leading meetings, as needed
Affiliating with professional organizations and participates in continuing education programs, conferences, seminars and workshops (as circumstances permit) in an effort to keep pace with regulatory guidances and client expectations
Staying within budget specifications for assigned projects, working within the budgeted hours and communicating any changes to specifications to Manager, Medical Writing or Project Manager, as appropriate
Completing administrative tasks within specified timeframes
Bachelor's degree in life science or clinical field; MS, MPH, PharmD, PhD, or other advanced life sciences degree preferred
Extensive experience in writing clinical regulatory documents in a pharmaceutical or CRO environment
Thorough knowledge of drug development process and regulatory guidelines
Knowledgeable of eCTD organization and preparation
Thorough knowledge of relevant GCP, ICH and FDA guidelines
Excellent proofreading, editing and internet research skills
Proficient in the use of English grammar, punctuation and spelling
Working knowledge of basic statistics with the ability to analyze descriptive and numeric data and present with clarity and accuracy
Thorough knowledge of clinical research design and methodology
Excellent organization and planning skills
Proficient in the use of MS office software and in the use of customized Word functionalities, including templates, style guides, table formatting and customized toolbars
Ability to develop good working relationships with internal and external colleagues
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