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| 28 September 2009 Published weekly by Biotech Ink, LLC |
Vol 2 No 28 | |
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| Greetings! |
 In previous issues of the Biotech Ink Insider, we've listed staff and contract jobs for medical writers, editors, science writers, regulatory publishers, and related positions. With this issue, however, we are broadening the scope of the job types that we publish.
While maintaining its medical writing focus, the Insider will also list jobs that include a strong writing or editing requirement. This means the Insider's job listings will be relevant to a wider readership.
Open jobs are hard to find, and the competition for them is fierce. We hope that the Insider will become a resource for you in your job junt. Please don't hesitate to send us your comments and ideas for newsletter content.
Warmest regards,
Susan
Susan E Caldwell, PhD
Managing Editor, The Biotech Ink Insider
Medical Writer Consultant and President
Biotech Ink LLC
Foster City, CA 94404
Tel: 650-286-9300
Fax: 650-286-9301
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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.
If you're a writer or editor and are getting calls about staff or contract positions you aren't interested in, please forward that job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
Systems Test Coordinator
Southern CA |
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Basic Qualifications:
- Bachelor's Degree in life science, computer science, engineering, business or related discipline
- 1 or more years of experience in quality assurance, business analysis, clinical research or data management.
Preferred Qualifications:
- Ideal candidate will possess proficiency in converting complex technical and business requirements into an understandable test plan and test cases
- Experience with clinical systems, such as CTMS, EDC, IVRS, Oracle Clinical or other related technology in the pharmaceutical/biotechnology industry preferred
- Candidates should demonstrate clinical and technical expertise, attention to detail, and excellent documentation and communication skills
- Knowledgeable in Good Clinical Practices, Software Development Lifecycle, and FDA regulations
- Excellent time management and organization skills required. Have sound problem resolution, judgment, and decision-making skills
- Be able to work well in a team-based environment with minimal supervision, and communicate effectively with clients, peers, and management
- Able to prioritize client needs and manage multiple projects simultaneously
Job Summary:
The role is focused on ensuring that outsourced electronic trial systems that are implemented within a clinical trial meet or exceed company qualitative expectations.
Key Responsibilities:
- Implement a logical, risk-based test approach
- Write clear, concise and thorough test documents
- Execute test cases according to the defined test plans and guidelines
- Perform peer review on project test documentation Facilitate project testing activity with Internal and External clients
- Coordinate project test efforts with multiple testers
- Investigate, track and manage findings
- Provide work status reports
- Participate in project status meetings
- Ensure the timely delivery of all client deliverables (internal and external
- Adhere to applicable policies, SOPs and guidelines
Contact:
Chad Dunavant 866-458-4322 etx. 19021 Cdunavant@pdstech.com
Phil Press 866-458-4322 etx. 19025 Ppress@pdstech.com |
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Technical Specialist |
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Basic Qualifications:
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Bachelor's Degree in life science, computer science, engineering, business or related discipline
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4 or more years of experience in clinical operations, clinical development or clinical quality assurance
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Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred
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Knowledgeable in Good Clinical Practices, and FDA regulations necessary
Preferred Qualifications:
- Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills
- Excellent time management and organization skills required
- Must have sound problem resolution, judgment, and decision-making abilities
- Must be able to work well in a team-based environment with minimal supervision
Job Summary:
The position will work with a cross functional team of Clinical, Biostatistical and Supply Chain representatives to support the design, implementation and maintenance of outsourced electronic solutions to support a clinical trial. The individual within this role will provide technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Key Responsibilities:
- Lead study level system requirements meetings with internal and external clients
- Design and oversee the development of study specific technical documents
- Document possible risk and implement mitigation plans
- Manage project related timelines and associated activities
- Identify and track study-related technical issues to resolution
- Provide a supportive framework for continuous process and quality improvements
Contact:
Chad Dunavant 866-458-4322 etx. 19021 Cdunavant@pdstech.com Phil Press 866-458-4322 etx. 19025 Ppress@pdstech.com |
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Business Analyst, Contract San Francisco Bay Area |
Contract assignment is for 2 months, located in the San Francisco Bay Area, CA.
Duties:
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Works closely with end users to analyze business requirements and translate them into functional requirements.
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Works with the development teams to design solutions.
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Participates in all phases of the systems development lifecycle - requirements definition to issues resolution, testing and implementation.
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Collaborate with Project Managers, Architects, Engineers, Developers, and
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Designers on scope, solutions, constraints, and risks
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Analyze/document current and future business process models
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Analyze/document high-level requirements (scope)
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Analyze/document detailed functional requirements and business rules (use cases)
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Analyze/document data requirements (from business needs perspective)
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Support planning of user acceptance test (UAT), including creation of UAT scripts
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Define high-level training approach
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Interface directly with business system owners to understand and document business processes and use cases for system enhancements and development
Preferred Qualifications:
- 5+ years Business Systems Analyst background with specific experience implementing Med Affairs (publications) solutions in the biotech/pharma industries.
- Must have full lifecycle experience on multiple projects, from requirements gathering through functional specifications/design and user acceptance testing.
- High level of customer service.
- Ability to rapidly understand business requirements and communicate business expectations to cross-functional development teams.
- Demonstrated ability to manage to a work plan/milestone dates
- Skills to gather and document requirements using process flows, use cases, interviews, workshops, and investigation of current state (existing systems and/or processes).
- Effective communication skills
- Good understanding of the standard project and SDLC methodologies.
Contact:
10900 NE 4th St. | Suite 2300| Bellevue, WA 98004
T: 866 492 8500 x 109/425-605-5446 | C: 425-408-3474 | F: 408 213 8515 | |
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