| 15 April 2011 Published weekly by Biotech Ink, LLC | Vol 4 No 7 |
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Inside the Insider | |
Open Jobs and Contract Opportunities
Senior Regulatory Medical Writer; Home based
Manager, Medical Writing and Scientific Communications; Home based
Contract Senior Regulatory Medical Writer; Home based |
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Jobs and Contract Opportunities |
 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.
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 caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
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Senior Regulatory Medical Writer
Home based |
For i3 Statprobe - Any US Location - Home Based
Description
As a division of Ingenix, a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses technology, integrity and innovation to create a health care system greater than many ever thought possible.
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. Our leadership and innovation in merging world-class process design and six-sigma quality, affords clients the ability to maximize efficiencies and exceed customer expectations. It also creates opportunities for career growth and success greater than you can imagine.
The Sr. Regulatory Medical Writer is responsible for developing, writing and editing clinical documents intended for use in regulatory activities.
Responsibilities
Develop tables, charts, figures and other display elements for clinical data
Comply with client or i3 Statprobe procedures for completing deliverables, obtaining reviews, incorporating edits and working with teams to finalize deliverables
Manage medical writing activities associated with individual studies and across departments, keeping management and team members informed of project status
Actively participate in team meetings, leading meetings as needed
Stay within budget specifications for assigned projects, working within the budgeted hours and communicating any changes to specifications to Manager, Medical Writing or Project Manager, as appropriate
Develop clinical regulatory documents such as CSRs, narratives, and Basic Results using client or i3 Statprobe templates
Qualifications
Bachelor's degree in life science or clinical field; MS, MPH, PharmD, PhD, RN, or other advanced life sciences degree preferred
Extensive experience in writing clinical regulatory documents in a pharmaceutical or CRO environment, particularly CSRs, narratives, and basic results.
Experience in diabetes (strongly preferred) as well as a variety of other therapy areas such as oncology, pain, cardiovascular, inflammation, ophthalmology, infectious disease.
Thorough knowledge of drug development process and regulatory guidelines
Knowledgeable of eCTD organization and preparation
Thorough knowledge of relevant GCP, ICH, and FDA guidelines
Excellent proofreading, editing and internet research skills
Proficient in the use of English grammar, punctuation and spelling
Working knowledge of basic statistics with the ability to analyze descriptive and numeric data and present with clarity and accuracy
Thorough knowledge of clinical research design and methodology
Excellent organization and planning skills
Proficient in the use of MS office software and in the use of customized Word functionalities, including Documentum, templates, style guides, table formatting, and customized toolbars
Ability to develop good working relationships with internal and external colleagues
Contact
Jessica Warchal
UNITEDHEALTH GROUP |Recruitment Services
E: jessica_warchal1@uhc.com | D:919.793.0196| F: 877.833.1194
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Manager, Medical Writing and Scientific Communications
Home based |
For i3 Statprobe - Any US Location - Home Based
Description
As a division of Ingenix, a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses technology, integrity and innovation to create a health care system greater than many ever thought possible.
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. Our leadership and innovation in merging world-class process design and six-sigma quality, affords clients the ability to maximize efficiencies and exceed customer expectations. It also creates opportunities for career growth and success greater than you can imagine.
i3 Statprobe is seeking an experienced Manager, Medical Writing and Scientific Communications, to provide overall management/supervision of assigned direct reports, oversees medical writing and report processing, assures compliance with regulations and timely completion of deliverables to clients, and consults with internal and external customers, as needed.
Primary Responsibilities
Ensures timely completion and delivery of work product to clients.
Ensures quality of work product delivered to clients.
Documents quality findings in written monthly summary reports to Global Director of Medical Writing and Scientific Communications.
Develops and maintains departmental Standard Operating Procedures (SOPS) for medical writing and report processing services.
Works with other relevant line functions to prepare documents, including Phase I- IV clinical study reports, Investigator Brochures, eCTD modules, protocols, and informed consent documents.
Provides technical review of documents, including Phase I- IV clinical study reports, Investigator Brochures, eCTD modules, protocols, and informed consent documents.
Actively supports ongoing business development efforts related to medical writing and report processing services.
Participates in presentations to clients for general capabilities as well as specific project proposals as needed.
Participates in professional meetings to enhance and maintain industry recognition of i3 Statprobe's medical writing and report processing capabilities.
Assesses departmental resource needs, collaborating with Human Resources on hiring, retention, and termination activities.
Ensures departmental adherence to agreed upon standards, templates and formats and document management procedures, including training of writers.
Mentors medical writers and other members of the project team who contribute to report preparation.
Qualifications
A bachelor's degree in a health- or scientific-related related field, M.S. M.A. MPH, PharmD, or Ph.D is preferred.
2 - 3 years relevant management experience, preferably in a CRO environment
5+ years experience in regulatory medical writing within the CRO, pharmaceutical or biotechnology industries
Neurology experience preferred
Excellent verbal and written communication skills, interpersonal skills, team skills, and presentation skills.
Understanding of the drug development process required.
Familiarity with regulatory clinical trial reporting guidelines, particularly ICH E3, required.
Strong management and independent work skills.
Medical writing experience in the preparation of Phase I through Phase IV clinical study reports and in the summarization and reporting of efficacy and safety data for regulatory filings (NDA/CTD).
Experience in the analysis, summarization, and interpretation of scientific data and an ability to communicate clinical data succinctly, clearly, and accurately in writing.
Contact
Jessica Warchal
UNITEDHEALTH GROUP |Recruitment Services
E: jessica_warchal1@uhc.com | D:919.793.0196| F: 877.833.1194
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Contract Senior Regulatory Medical Writer
Home based |
For i3 Statprobe - Home Based - 348583
Description
As a division of Ingenix, a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses technology, integrity and innovation to create a health care system greater than many ever thought possible.
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. Our leadership and innovation in merging world-class process design and six-sigma quality, affords clients the ability to maximize efficiencies and exceed customer expectations. It also creates opportunities for career growth and success greater than you can imagine.
The Contract Regulatory Medical Writer is responsible for developing, writing, and editing clinical documents intended for use in regulatory activities.
Responsibilities
Develop clinical regulatory documents such as CSRs, narratives, and Basic Results using client or i3 Statprobe templates
Develop tables, charts, figures and other display elements for clinical data
Comply with client or i3 Statprobe procedures for completing deliverables, obtaining reviews, incorporating edits and working with teams to finalize deliverables
Manage medical writing activities associated with individual studies and across departments, keeping management and team members informed of project status
Actively participate in team meetings, leading meetings as needed
Stay within budget specifications for assigned projects, working within the budgeted hours and communicating any changes to specifications to Manager, Medical Writing or Project Manager, as appropriate
Qualifications
Bachelor's degree in life science or clinical field; MS, MPH, PharmD, PhD, RN, or other advanced life sciences degree preferred
Extensive experience in writing clinical regulatory documents in a pharmaceutical or CRO environment, particularly CSRs, narratives, and basic results.
Experience in vaccines, oncology, and a variety of other therapy areas such as pain, cardiovascular, inflammation, ophthalmology, infectious disease.
Thorough knowledge of drug development process and regulatory guidelines
Knowledgeable of eCTD organization and preparation
Thorough knowledge of relevant GCP, ICH, and FDA guidelines
Excellent proofreading, editing and internet research skills
Proficient in the use of English grammar, punctuation and spelling
Working knowledge of basic statistics with the ability to analyze descriptive and numeric data and present with clarity and accuracy
Thorough knowledge of clinical research design and methodology
Excellent organization and planning skills
Proficient in the use of MS office software and in the use of customized Word functionalities, including Documentum, templates, style guides, table formatting, and customized toolbars
Able to develop good working relationships with internal and external colleagues
Contact
Jessica Warchal
E: jessica_warchal1@uhc.com | D:919.793.0196| F: 877.833.1194 UNITEDHEALTH GROUP |Recruitment Services
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