| 28 January 2011 Published weekly by Biotech Ink, LLC | Vol 4 No 2 |
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Inside the Insider | |
Open Jobs and Gigs
Senior Medical Writer, Contract; Telecommute Position
Medical Writer, Contract; Telecommute Position
Medical Writer, Clinical Research; North Chicago, IL
Senior Manager, Biostatistics--Phase 1/PK Studies; Bay Area, CA
Manager of Biostatistics; Bay Area, CA
Clinical Statistical Programmer, Contract; Chicago, IL area
Senior Biostatistician; Redwood City, CA
Clinical Safety Associate; South San Francisco, CA |
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Open Jobs and Gigs for Medical Writers |
 The 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 are 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 caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
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Senior Medical Writer, Contract
Telecommute Position | |
Job Description
Sr. Medical Writer for 6 month contract to start this could last as long as 2 years
20-40 hrs a week remotely
Experience with Osteoporosis a must
Candidate should work well in teams and be able to conduct roundtable meetings
Would be working on CSR's, Investigative brochure's etc...
Ability to summarize documents and write responses
Contact
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
100 Unicorn Park Drive
Woburn, MA 01801
100 Unicorn Park Drive
Woburn, MA 01801
Direct line: (781) 496-3133
Direct fax: (866) 855-5872
Email: JLeveille@orbisclinical.com
Web: www.orbisclinical.com |
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Medical Writer, Contract
Telecommute Position | |
We are working with our client in locating a Medical Writer with strong Medical/Scientific knowledge and experience who will work on posters and manuscripts. The client audience is diagnostic laboratories and physicians who diagnose sexually transmitted diseases.
Required Skills:
- 5+ years medical writing experience
- Strong Medical/Scientific knowledge.
- Experience in writing about Medical or Diagnostic Devices.
- Experience writing peer-reviewed articles
- Experience writing articles on STD (sexually transmitted diseases) topics
Start Date: ASAP
Duration: 130 hour over the next 6 months
Location: 100% Virtual
NOTE: 100% Remote Positions
Due to the nature of this virtual position, we anticipate a high number of responses from interested applicants. We may not be able to personally respond to your inquiry immediately but please know that your resume and email responses will be reviewed. Please send the recruiter an email containing your contact number and available time slots that you're available to discuss this opportunity.
Contact
To apply, please send a Word version of your resume and a summary of your relevant skills and or experience as they relate to the job requirements to kspeidel@claritytechwriters.com. Please be sure to include the Job #GHM3956 in the subject line.
Clarity Technical Communications represents a world of opportunity for professionals who specialize in corporate communications. When Fortune 500 firms have technical documentation needs, they call us first! We get new opportunities daily. If the above opportunity is not for you and you are a technical documentation professional, please send your resume, along with a brief cover letter listing your experience and skills, to register@claritytechwriters.com.
If you have advanced skill in the area of corporate communications, technical writing and medical writing, we want to hear from you! For more info, visit us at www.claritytechwriters.com. |
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Medical Writer, Clinical Research
North Chicago, IL | |
North Chicago, on-site W-2 contract
Responsibilities
Assist Project Manager(s), Clinical Trial Registration & Results Disclosure (CTR/RD) with the oversight and project management of the planning and execution of clinical drug trial results disclosure postings per the applicable regulatory requirements.
Specifically, responsible for assisting in ensuring that all applicable trials have results disclosed on ClinicalTrials.gov with accurate and complete data
May prepare technical documents to support both domestic and international regulatory submissions
Prepares technical documents to support both domestic and international regulatory submissions.
Incorporates text, graphs, charts, tables and statistical analysis.
Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.
Requires a Clinical Background
Bachelor's degree or equivalent relevant experience is required preferably in nursing, pharmacy or scientific field.
Clinical research experience or in a related area such as quality or regulatory
Contact
Please email Lindsey Summers at lsummers@ascentsg.com, or call 303-694-5482. PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
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Senior Manager, Biostatistics--Phase 1/PK Studies
Bay Area, CA | |
Permanent on-site position
Responsibilities
Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance.
Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources.
Leads two or more components of departmental strategic initiatives.
Excellent verbal and written communication skills and interpersonal skills are required.
Examines functional issues from a broader organization perspective.
Proven ability to determine the functions most critical to company success and to support priorities within functional area.
Anticipates obstacles and difficulties of clients and acts to meet goals.
Proven ability to pull together and lead highly effective teams and create a clear sense of direction.
Proven ability to design and use all available vehicles for effective scientific communication within and outside the company.
Must be able to directly supervise personnel.
Requirements
7+ years with MINIMUM MS degree, PhD preferred
Contact
Please email Lindsey Summers at lsummers@ascentsg.com, or call 303-694-5482. PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
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Manager of Biostatistics
Bay Area, CA | |
Permanent on-site position
Responsibilities
Primary responsibilities include: provides statistical consultation on trial design and study endpoints, calculates sample sizes and authors statistical analysis plans, utilizes knowledge of Regulatory requirements and guidance documents to provide statistical advice with respect to creating a clinical development program, and uses knowledge of literature to provide data analysis and presentation methods to support publications/presentations.
Works on 4-6 clinical trials / projects as well as other tasks as assigned by supervisor.
Leads a specific component of a departmental strategic initiative.
This key role will be a statistical lead on a number of projects, many involved with new drug applications to the FDA.
This position will work collaboratively with Statistical Programmers, Biostatisticians, and Clinical groups on Phase I trials, mostly in the HCV arena but could also work on other infectious diseases.
Requirements
PhD REQUIRED and minimum 2 years of relevant industry experience in the statistical analysis of biomedical data using SASŪ software.
Ideal candidate will have 4-6 years pharmaceutical industry experience and possess a PhD.
Extensive Phase III trial experience is highly preferred.
Contact
Please email Lindsey Summers atlsummers@ascentsg.com, or call 303-694-5482. PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
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Clinical Statistical Programmer, Contract
Chicago, IL area | |
6-month contract
Description
Statistical programming support for the analysis of data of studies related to the design and evaluation of diagnostic assays
Program statistical analyses and results report summaries in SAS
Debug programs, generate tables, listings, graphs, plots. Document programming procedures and coding
Participate in the design of programs, data collection procedures, information flow, analysis plans, and reports related to the studies
Interact with database developers, project managers and other statisticians.
Produce ad hoc analysis requests and reports
Skills
BS/MS degree in computer science, mathematics, statistics, or related areas of study
Strong knowledge of SAS programming, preferable in a diagnostic or pharmaceutical industry REQUIRED
Versed on Visual Basic, C, or a mathematical programming language highly desirable
Contact
Please email Lindsey Summers at lsummers@ascentsg.com, or call 303-694-5482. PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
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Senior Biostatistician
Redwood City, CA | |
W-2 only, on site
Responsibilities
Apply statistical expertise to ensure optimal clinical trial designs and statistical analysis methods
Plan, coordinate and produce statistical plans for clinical programs throughout the life cycle of the responsible compounds
Help devise data capture methods (case report forms or other) for pertinent clinical programs
Create statistical analysis plan and perform analyses according to established program standard for responsible clinical programs
Assist in final study report writing and ensure accurate reporting of the analysis outcomes
Work with the Director of Biostatistics and the clinical development teams to standardize the statistical analyses and outputs for the responsible programs
Assist/mentor/supervise junior level biostatisticians on clinical trial design and statistical analysis as needed
Direct external (CRO) data management efforts, as needed
Direct the activities of internal and/or external bioanalysts/SAS programmers as they pertain to the above responsibilities
Attend regulatory meetings and support/defense the responsible clinical programs.
Requirements
Master's degree minimum, PhD in Biostatistics preferred
Minimum of 6-8 years experience in pharmaceutical or biotechnology industry
Must have experience preparing analysis programs for clinical trials phases I-III.
Must have been primary statistician on at least one NDA/BLA
Must have sound knowledge of statistical applications for clinical trials
Excellent writing and communication skills, and knowledge and skills of programming important
Strong knowledge of and experience in clinical trials design
Very good knowledge of drug development regulations pertinent to trial design and statistical analysis
Contact
Please email Lindsey Summers at lsummers@ascentsg.com, or call 303-694-5482. PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry. |
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Clinical Safety Associate
South San Francisco, CA | |
W-2, on-site
Description
Demonstrates knowledge of safety concepts (ICH and FDA guidelines).
Performs a review of ancillary documentation accompanying individual case safety reports (ICSRs) and identifies pertinent clinical information for incorporation into the case narrative.
Performs data entry and coding in safety database for all molecules.
Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
Assists in clinical trial data reconciliation process as necessary.
Organizes work load to ensure compliance with regulatory time lines for ICSR reporting.
Ensures departmental work flow processes and time lines are followed
Requirements
RN, BSN , PA , NP, MSN , MD , or PharmD REQUIRED
Minimum 2 years of clinical experience in a health care related field
Computer proficiency required, data entry/safety database experience highly preferred
Excellent communication skills, both written and verbal
Previous experience in Drug Safety or other similar pharmaceutical industry experience
Works effectively as a team member and promotes collaboration.
Demonstrates initiative and accountability.
Strong organizational skills, detail-oriented, and ability to adapt to change.
Confident decision maker
Contact
Please email Lindsey Summers at lsummers@ascentsg.com, or call 303-694-5482. PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
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