1 October 2010                 Published weekly by Biotech Ink, LLCVol 3 No 25

Angel Bivins photo

Inside the Insider

Manager of Medical Writing; Midwestern US

Senior Medical Writer, Regulatory; Home Based

Join Our Mailing List!

Send to a Colleague
 
Open Jobs and Gigs for Medical Writers
 
Susan E Caldwell, PhDThe 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.
aManager 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.
 
Contact:
 
E-mail your CV/resume Kathryn Crone, Smith Hanley Associates, at [email protected], or call 212-915-0500.
aSenior Medical Writer, Regulatory
Home Based
 
Job Description:

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. 


Responsibilities:

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

 
Qualifications:

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

 
Contact:
 

To apply, email Jessica Warchal at [email protected].

Biotech Ink's Links

Biotech Ink Spots
medical writing blog

Biotech Ink Insider medical writing newsletter information web site 

Biotech Ink Insider medical writing newsletter archives
Susan Caldwell's Medical Writing Twibe (a special-interest Twitter group; Twitter account required)

Susan Caldwell on Twitter

Susan Caldwell on Facebook 

Comments or questions? Email Susan at [email protected].