3 September 2010                 Published weekly by Biotech Ink, LLCVol 3 No 24

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Inside the Insider

Regulatory Medical Writers (Clinical); Northern NJ, On Site

Medical Writing Coordinator/Specialist; Northern NJ, On Site

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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.
aRegulatory Medical Writers (Clinical)
Northern NJ, On site
 
Length of Assignment: 6 months contract-to-perm

Start Date: As soon as possible

Client: Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company whose purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets.
 
Position: The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. This person will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
 
Please note:  We are not looking for manuscript writers, tech writers, drug safety specialists that have written sections of submissions, no writers that only do slide kits and presentations, etc. Must be regulatory/clinical writer. Also, editing/review experience is not enough.

Must have written at least 2 different types of documents (protocols, IBs, CSRs, etc)

It's ok if they haven't authored a full submission.
 
Responsibilities:

Assuring quality and timely preparation of regulatory documents across all therapeutic areas.
 
Required Skills:
 
BS or equivalent with 6 years experience in a scientific discipline and a minimum of 4 years in Medical writing

OR

MS, PhD, or equivalent with a minimum of 2 years previous industry writing experience
AND

Excellent written and oral communication (English)

Demonstrated working knowledge of scientific principles

Familiarity with all phases of medical research and ability to learn new medical concepts quickly

Familiarity with statistics and experimental design

Ability to summarize complex data and identify relationships

Contact:
 
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
Direct line (781) 496-3133
Direct fax (866) 855-5872
Email [email protected]
100 Unicorn Park Drive
Woburn, MA 01801
bMedical Writing Coordinator/Specialist
Northern NJ, On site
 
Length of Assignment: 6 months contract to perm

Start Date: As soon as possible
 
Client: Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company who's purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets.
 
Position: The Medical Writing Specialist is responsible for tracking, quality control, and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents. This individual will not be writing the content of the submissions, but will review, edit and compile the components prior to publishing. 
 
Responsibilities:

Work together with key interface partners (ex: Study Management, statistics, and Programming) to facilitate the completion of clinical study reports and their appendices.

Using project management skills to track, review and ensure timely completion of high quality regulatory documents

Ensure the study file components (ex: Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements

Act as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guidelines to reflect new agreements and changes due to SOPs and regulatory guidelines

Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent

Performing real-time edits to clinical documents during comment review and resolution meetings

Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation and electronic publishing

Managing the review and approval of documents in the document management system using standard procedures
 
Required Skills:
 
BS or AS degree

Strong electronic documentation and word processing skills

Excellent written and oral communication (English)

Excellent interpersonal skills

Familiarity with clinical research, statistics, and regulatory submission requirements

Understanding of regulatory guidelines (ICH, FDA, etc)

Experience in a Medical Writing group would be a plus!
 
This is a document formatting position, and 90% of it is formatting in Word

Must be an expert in Word and formatting in Word, no exceptions - should know all the ins and outs, can format, style, design templates, etc.

Document management system knowledge is important

Adobe experience is important

Med Writing experience would be extremely helpful
 
Contact:
 
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
Direct line (781) 496-3133
Direct fax (866) 855-5872
Email [email protected]
100 Unicorn Park Drive
Woburn, MA 01801
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Susan Caldwell's Medical Writing Twibe (a special-interest Twitter group; Twitter account required)
 
Comments or questions? Email Susan at [email protected].