18 February 2011                 Published weekly by Biotech Ink, LLCVol 4 No 5

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Inside the Insider

Open Jobs and Contract Opportunities
 

Medical Writer; Telecommute in Boston, MA Area
Biostatistician; Pleasanton, CA

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Jobs and Contract Opportunities
 
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. 

The Insider lists job and contract opportunities 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.

Medical Writer

Telecommute in Boston, MA Area

 

Our client is a global leader in the development, manufacture and distribution of medical devices, diagnostic imaging products, and pharmaceutical products.  They are based in the greater Boston , MA area and last year posted over $10 billion in annual sales. We have been retained by the Clinical Affairs group to provide a medical writer to assist them with ongoing, time-sensitive project work.

 

Current Situation

 

This Clinical Affairs group is part of the Medical Supplies organization.  This group has product responsibility for sutures and wound care products, needles and syringes, and general surgical supplies. One of their more pressing projects involves updating the product information that is kept on file.  This group currently has one full time and one consultant focused on this work.  Based on forecasted workload, this group will need to add at least one additional medical writer to assist with this and other related projects.

 

Daily Responsibilities

 

This consultant will report to the Manager of Clinical Data and the Director of Clinical Affairs for the duration of this engagement.  Work will be assigned on a daily/weekly basis by the Manager of Clinical Data.  The consultant will be responsible for ensuring that the required Clinical Literature Reviews (CLRs) are updated and completed for their various products per the clients Medical Device Standards, as well as client SOPs. This consultant would also be responsible for performing relative article searches via the PubMed and OVID database system. Additionally, all writers must obtain information from the FDA MAUDE database system, which lists adverse events for comparable products on the market.

 

The medical writer creates and documents clinical literature reviews for regulatory purposes.  These measure the safety and efficacy of the product, complaints, and market history. The writer may also write submissions for publication, marketing use, as well as for in-house use. Additionally the writer will review documents written by other subcontractors and client employees for correctness and their intended uses and for accuracy of content. Editing for English grammar may be required for documents written by non-English speakers. A report of deficiencies found should be created along with the edited document.

 

General Workflow

 

Consultants will be asked to work primarily from home. There will be periodic on-site meetings that each consultant will need to attend. Work will be assigned via TC and or email. The client's goal is to have each clinical literature review written, reviewed, and approved within four weeks of assignment. The actual timeframe may vary depending on product complexity, number of documents to review and analyze, and the availability of staff to review and comment on each draft. A template will be provided by the client for this work. In addition to the completed template, the consultant will be required to return a summary of query results, etc.

 

Required Skills

 

The ideal candidate will be an RN or similar medically trained person with practical experience using these products.

This role requires someone that has a demonstrated track record of working independently when performing similar work.

This consultant will need to live within driving distance to the client site in the event on-site meetings are requested.

MS Word, Outlook, and PubMed and/or Ovid experience.  

Education and/or training that ensures this person is knowledgeable in medical procedures (RN or similar), terminology, literature searches and regulations that pertain to the documents being created.

It is essential that this person be proficient in medical writing, able to create documents that are complete, logical and accurate.

 

Interview Process

 

Candidate profiles will be sent to the client for review. Client has agreed to provide feedback within 48 hrs of receiving profile. It's likely that qualified candidates will be asked to participate in a phone screen and on-site interview. Candidates should be prepared to provide writing samples for client review. During the on-site interview the client will have the candidate take a test designed to measure proficiency with PubMed, OVID, and FDA Maude. Successful candidate will begin work late February/early March.

 

Unique Attributes

 

This is primarily a remote engagement.  However, the successful candidate will need to live within reasonable driving distance to the client site for periodic on-site meetings and training sessions.


Client will provide a preconfigured laptop for this project.

The client maintains a business-casual on-site work environment.

 

Contact

 

Jessica Leveille 

Manager, Biomedical Delivery Services at Orbis Clinical

Direct line (781) 496-3133

Direct fax (866) 855-5872

Email [email protected]

Web www.orbisclinical.com

100 Unicorn Park Drive

Woburn, MA 01801 

 

 

 

Biostatistician

Pleasanton, CA Area


This is a 12-month contract position. The Biostatistician acts as an in-house statistical consultant.

Responsibilities

Provides consulting services, analyses and statistical reports to Scientists.

This individual interacts with clients on a regular basis and translates the scientific question into statistical question, determines the necessary statistical tools and performs the data analysis.

The projects are short term and require quick turnaround time to deliver results.

For Clinical consulting, the individual provides statistical consulting to clinical teams in design of clinical studies (including sample size estimation, power calculation and study conduct), as well as analysis and interpretation of study data. Provide statistical methodology section for study protocols, write statistical analysis plans, perform statistical analyses and draft statistical reports as required.

Need a professional who exercises judgment within a broadly defined practice and policy in selecting methods, techniques, and evaluation criteria for obtaining results.

Develop systematic documentation of methods, results and statistical programming.

Statistical programming may include creation of analysis specified in statistical analysis plans and ad-hoc analyses. Coordinate the quality-control checking of deliverables (reports, summary tables and graphs). Attend project team meetings and provide expertise.


Requirements


Master's or PhD  in biostatistics or statistics is required with 5+ years experience.


A thorough knowledge of experimental design, general linear model, categorical analysis, and statistical computing is needed. Familiarity with linear mixed models, nonlinear models, and survival analysis is ideal.


Statistical computing in SAS is required.

 

Contact 


If you are available and interested, please call Sudha Param at 925-467-0725, or email

[email protected].

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