January 23, 2009  |  Vol. 2 No. 3     Published by Biotech Ink, LLC, and Word Angel Document Design Solutions
The Biotech Ink Insider

Inside the Insider

Open Medical Writing Staff and Contract Jobs

Medical Writer (Title Not Specified)
San Francisco Bay Area
Participate in writing papers and making presentations; participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.; writes study protocols, protocol amendments, Document management, SOPs, PowerPoint slide creation, editing, assisting/incorporating changes in reports (CSR-clinical study reports), annual reports, protocols.
 
Routing of materials through A and P process.
Good grasp of English, written and verbal.
 
Minimum Bachelor's or Master's of Science with writing experience. PhDs with writing experience preferred.
Proficiency in MS Word, Excel, PowerPoint, experience or ability to learn.
Familiarity with clinical trials or medical documents strongly preferred
 
Must have a writing sample submitted with resume, per manager's request.
 
1-year contract in Santa Clara.
 
Thanks!
 
Elizabeth Tse
TECHLINK SYSTEMS INC.
PHONE: 415-732-7580 x146   
Fax: 415-732-7583
EMAIL: [email protected]
URL: www.techlinksystems.com 
 
New York ~ San Francisco ~ Los Angeles
Honored as an INC 500 member of the Fastest Growing Companies for 2006, 2007, and 2008.
TA-12098-1 - Mgr, Clinical Medical Writing
Westlake Village, CA
Job Description: Our client is a global biotechnology and medical products company, has been recognized as a great place to work and learn. We are seeking a Sr. Manager, Medical Writing to join the Clinical Scientific Affairs team in the Global Clinical and Medical Affairs (GCMA) Department at the Westlake Village, CA headquarters.
 
Responsibilities: The Sr./Manager will work in a dynamic, cross-functional, team-based environment that fosters collaboration, trust, clinical and scientific excellence, creativity, and continuous improvement while ensuring the completion of high-quality documents within time and budgetary constraints. The Sr./Manager will develop our clinical trial results disclosure process for GCMA-sponsored studies in collaboration with representatives from other divisions and will be accountable for the timely public disclosure of these results. The Sr./Manager will drive the development of clinical documents in 1 or more therapeutic areas, ensuring compliance with international requirements for submission of investigative and licensing applications to worldwide regulatory authorities. The Sr./Manager will also develop and subsequently manage our manuscript/abstract preparation process for GCMA-sponsored studies, supporting the dissemination of our study information to scientific/medical communities and the sales and marketing efforts. The Sr./Manager will participate in the selection and management of contractors/contract organizations to support clinical document preparation.
 
Position will require 5-10% travel.

Job Requirements Expert knowledge of international regulations, requirements and guidance associated with document preparation and submissions � Collaborative teamwork and management track record � Excellent business communication skills with aptitude for summarizing complex information as well as meticulous attention to detail � Expertise in the analytical evaluation of scientific data � Competence in leadership and project management skills � Working knowledge of current electronic document management systems and information technology beneficial.
 
Education: Advanced scientific degree with direct experience in scientific/medical writing in the healthcare industry, preferably a PhD with at least 5 years of additional writing experience, or Master's Degree with at least 7 years of experience, or Bachelor's Degree with at least 9 years of experience.

Salary: to $140K,  
Job Type: Permanent  
Total Exp: 5 Years  
Start Date: ASAP  
Location: Westlake Village, CA

Respond to this Job by eMail    Respond to this Job by Web Form
Sr. Medical Writer
San Francisco Bay Area
I am looking for a Sr Medical Writer to work full time.  The position is in house, however telecommuting options may be available in the future.  It is a collaborative environment that has energy!
 
Company

Small public company that is well funded!
Marketed products
Stable and in growth mode
 
Position

Sr Medical Writer
Responsible for writing clinical documents
Assist with generation of Regulotory Submission Documents
 
Must-Haves

BS, MS, or Ph.D. (scientific or medical field is a plus)
Minimum 5 years in the Biotech/Pharmaceutical Industry
Has worked on at least one NDA submission
Has written CRF's
 
Ideally a self-starter who can "hit the ground running"!
 
For further information please contact:
Bonnie Gothmann
Vice President, Executive Search
Corporate Search
415-296-9692 X 106
[email protected]
Associate Director/Director, Medical Writing
San Francisco Bay Area
I am looking for an Associate Director/Director, Medical Writing.  This is a full-time, in-house position.  Given the economic times, they are one of my few clients that are doing well.  $$$$, marketed products and hiring!!  The Medical Writing group is respected and regarded as the experts.
 
The Associate Director/Director of Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff and is responsible for departmental resource planning, contributes to submission planning for program and product development, represents Medical Writing in communications with regulatory agencies, and may participate in review and approval of regulatory submission documents and publications.
 
MS or higher degree preferred; scientific focus desirable.
 
Responsible for up to 5 medical writers and 1 project coordinator as functional reports.  Up to 2 Medical Writing Managers as direct reports and may manage the writing efforts of contractors.
 
For further information please contact:

Bonnie Gothmann
Vice President, Executive Search
Corporate Search
415-296-9692 X 106
[email protected]
3 Writing Positions
Atlanta, GA

All open positions are on-site/full time positions in an agency:

Scientific Director - should have CME diabetes experience, PharmD, PhD, or MD degree- heavy writing/strategic role

Medical Writers- would like PharmD degrees and transplantation clinical experience

Editorial Director with oncology experience

Anyone interested, please connect with me.

Best Regards,

Shannon Peryea
Vice President, Executive Recruiting
Sheila Greco Associates, LLC
174 State Hwy 67
Amsterdam, NY 12010
(518) 843-4611 ext. 252
[email protected]
http://www.sheilagreco.com
Celebrating 20 Years of Excellence!
DISCLAIMER:  Biotech Ink, LLC, and the Biotech Ink Insider provide the Insider jobs list on an "as-submitted basis," and neither assumes responsibility for, nor guarantees the quality or accuracy of, any listing or response. All listings are provided as a free service and courtesy to subscribers and users, and users assume all risk in using the information in the Insider