16 November 2009                 Published weekly by Biotech Ink, LLC Vol 2 No 35

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Open Jobs and Gigs for Medical Writers
 
The jobs listed in the Biotech Ink Insider come to us mostly by word-of-mouth and direct contact with hiring managers and recruiters. If no new jobs are communicated to us in a given week, the Insider won't be published that week. See also our disclaimer at the bottom of the newsletter.
 
Because of the tough job market in recent months, we are now publishing jobs that are closely related to medical writing, or that have a strong writing role, regardless of their titles.
 
If you're a writer or editor and are getting calls about staff or contract positions 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 Affairs Content Development Scientist
South San Francisco, CA
 
Position Description
 
On-site, full-time, 3- to 6-month contract with a biotechnology company
 
Duties
  • The Medical Affairs Content Development Scientist is responsible for establishing and leading the Medical Affairs (MA) portal content team and managing the portal content process to provide relevant and timely clinical information to healthcare professionals (HCPs)
  • Coordinates and manages Roche Exchange.com and other related medical portal content projects to ensure alignment with MA goals and priorities.
  • Chairs the Content Domain Team and ensures delivery of content strategy.
  • Provides guidance and resources to the content sponsor and team for the identification, creation, and implementation of medical content and initiatives
  • Works closely with internal teams to lead the development of annual content strategy and plan revisions.
  • Ensures consistent implementation of medical content across therapeutic areas.
  • Has a well developed understanding of legal, regulatory, and compliance topics issues that includes but is not limited to scientific information exchange, medical information best practices, promotional materials, web publishing, copyright, etc.
  • Ensures appropriate internal team/medical/legal review of information prior to portal publication.
  • Provides guidance on the training and implementation of legal and regulatory SOPs and other related guidelines.  Also develops, updates, and implements applicable SOPs/Working Documents and business processes
  • Reviews and provides guidance to content vendors.
  • Manages content development budget for each therapeutic area (news service, reprints, etc.).
  • Develops content templates and reviews/assigns medical content using key words and metadata.
  • Develops content calendars to ensure ongoing content development and posting.
  • Works with the portal operations manager to evaluate analytics of content applications to enhance and provide recommendations to continually enhance the portal mission and project.
  • May manage personnel by utilizing work values that include but not limited to: achieving results through others, delegating enjoyable work, engaging and coaching, providing role clarity and constructive feedback; evaluates resources, delegates responsibilities, and explores new ideas/opportunities
Education and Other Requirements
  • Scientific or health sciences degree (RN, PharmD. MD, PhD., etc. or equivalent) with minimum 3+ years of relevant prior industry experience (e.g. medical information, medical liaisons, publications, medical writing, medical education, etc.)
  • Strong written, verbal, computer, and interpersonal skills.
  • Ability to prioritize and manage multiple tasks and projects; lead teams, work independently, collaborate with others and within cross-functional teams; make sound decisions
  • Must convey a professional attitude, demonstrate attention to detail, and possess flexibility and self-motivation
  • Strong project management, leadership, strategic thinking skills, and business acumen are highly desirable
Contact
 
Please email Lindsey Summers at [email protected] for consideration.

PharmAscent, a Division of Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
Senior Medical Writer
South San Francisco, CA
 
No telecommute option available.
 
Responsibilities
  • Writes and edits various documents to support Clinical Development. Such documents may include study protocols, investigator brochures, clinical study reports, INDs/NDAs, study manuals, and posters/slide decks.
  • Edits, rewrites, or otherwise prepares drafts of clinical protocols and investigator brochures, CSRs, INDs, etc.
  • Compiles, analyzes, and summarizes data from other sources as needed.
  • Manages compilation of the components of complex submissions.
  • Communicates with external vendors as needed.
  • Integrates various sources of information into a uniform style and language for regulatory compliance.
  • Strong editorial and formatting skills are required.
Experience 
  • Prior medical technical writing experience within the biotech/pharmaceutical/CRO realm.
  • Experience and significant participation in preparation of clinical documents for regulatory submissions (eg, clinical protocols, IBs, INDs, NDAs, BLAs).
    Proficient in Microsoft Office suite.
  • Ability to incorporate diverse feedback into a high quality document.
  • Determines methods and procedures on new assignments.  
  • Has good general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
  • Applies strong analytical and business communication skills.
  • Typically requires a minimum of 5 years of related postgraduate experience and/or combination of experience and education/training.
  • Biotechnology/pharmaceutical/CRO experience
Education
 
BA/BS degree in related discipline, or MS/MA degree in related discipline, or PhD degree in related discipline, or equivalent combination of education and experience.
 
Contact
 
If intererested and available, please send a Word doc of your resume to Sudha parameswaran at Buxton Consulting at [email protected].
Biostatistician
Pleasanton, CA
 
Develop systematic documentation of methods, results and statistical programming; 12-month contract. The Biostatistician acts as an in-house statistical consultant, and will provide consulting services, analyses, and statistical reports to scientists.
 
Position is onsite; no telecommute option at this time.
 
Responsibilities
  • 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 turn around 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.
  • Statistical programming may include creation of analysis specified in statistical analysis plan and ad hoc analysis.
  • Coordinate the quality-control checking of deliverables (reports, summary tables and graphs).
  • Attend project team meetings and provide expertise.
Experience 
  • Masters or PhD degree in biostatistics or statistics is required with 5 years experience.
  • Statistical computing in SAS is required.
  • Knowledge of other statistical software such as S-Plus, nQuery or PASS etc would be good to have.
  • 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.
Contact
 
If intererested and available, please send a Word doc of your resume to Sudha parameswaran at Buxton Consulting at [email protected].
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Comments or questions? Email Susan at [email protected].