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| 31 May 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 16 |
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Inside the Insider
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Networking and Learning | Principal Medical Writer, Contract; Cambridge, MA | Senior Manager Medical Writer; Gaithersburg, MD | Biostatistician; Irvine, CA | Technical Writer; Irvine, CA | Senior Medical Writer, Contract; Cambridge, MA | Medical Writer (Publications), Contract; Seattle, WA | Medical Writer; Northern NJ | Senior Medical Writer; Washington, DC Area |
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Networking and Learning  |
Regulatory Affairs Professionals Society (RAPS) San Francisco Chapter:
Introduction to Regulatory
Date and Time: 21 June 2010, 5:30 pm-8:30 pm
Place: Varian Medical Systems; Palo Alto, CA
Cost: $15
Are you interested in learning about the regulatory profession but don't know who to ask? The San Francisco Bay Area Chapter of RAPS has assembled a panel of regulatory experts to provide insight into regulatory affairs and answer your questions about this important and growing profession.
Whether you are new to regulatory or are thinking about an exciting new career option, don't miss this opportunity to network with regulatory veterans, who will share their experiences and insight about what it takes to get into and succeed in the regulatory arena.
Refreshments will be provided to meeting participants.
Topics:
Range of regulatory specialties in the medical device, pharmaceutical and biotechnology sectors
Job responsibilities: a day in the life of a regulatory professional
Pathways into regulatory careers
Current opportunities and salary ranges
Speakers:
Mike Johnston, director, regulatory affairs, Quark Pharmaceuticals Craig Halverson, senior consultant, regulatory affairs, Biologics Consulting Group Additional speakers to be announced! |
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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 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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Principal Medical Writer, Contract Cambridge, MA |
Job number: 558 Job title: Principal Level Medical Writer Duration: 3-6 months contract Location: Cambridge, MA Rate: Open Requirements:
Extensive regulatory writing background within the biotech industry.
Must be experienced and effective working under aggressive timelines.
Protocol writing experience with regard to designing studies for clinical trials, drug safety programs, clinical/pharma vigilance programs.
Experience in helping to produce clinical protocols, clinical study reports, and new programs.
Experience with marketing apps and seeing them through to post marketing.
Must be a great communicator and effective working in a team environment.
Daily Responsibilities:
Prepare clinical regulatory documents such as protocols, IBs, CSRs, Clinical summary documents, etc.
Represent department at team meetings.
Interface and coordinate with project team and other writers.
Prepare documents by other writers, as needed.
Contact:
Jaime Biggs | Director of Recruitment
Ivesia Solutions, Inc.
2 Keewaydin Dr. Salem, NH 03079
Tel: 800-871-1510 x 2407 | Tel: 603-685-2407
Fax: 603-890-1276
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Senior Manager Medical Writer, Contract Gaithersburg, MD |
MAIN PURPOSE OF ROLE: To lead the medical writing function for our client's clinical development. A strategic and proactive role with responsibility for ensuring the function is professionally led and represented both within and external to the company, providing support and expertise to members of the clinical team. This role includes providing and overseeing medical writing aspects of several outsourced clinical research programs securing quality and best value at all times.
Key Responsibilities:
Author clinical submission documents and manuscripts, including: clinical study reports (CSRs); clinical study protocols; informed consent forms; investigational brochures; statistical analysis plans; safety monitoring committee/data safety monitoring committee charters; summary documents (including integrated summary of safety [ISS], integrated summary of efficacy [ISE], clinical overview, clinical summary CTD sections); risk management plans; summary of product characteristics and US package circulars; clinical sections of integrated product reviews; clinical development plans; manuscripts and abstracts for publication; clinical sections of grant and contract proposals to NGO and government partners; regulatory meeting briefing packages; IND and EU Annual Safety Updates; responses to agency questions; and other documents that may be assigned.
Detailed Responsibilities:Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner Provide process, content, and submission/document planning expertise; advise team on resource utilization, efficiencies, timelines and interdependencies Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style Reviewing protocols, statistical analysis plans and tables figures and listings Prepare abstracts and articles Ensure adherence to established regulatory, company SOP, and house styles, general quality, and ICH/GCP guidelines Write, review, and update company SOPs and related templates (eg CSR, protocol, narratives, IB) Prepare and represent Medical Writing for internal (QA) and external audits (MHRA, FDA) Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents; continually share best practices in an effort to create higher quality documents more efficiently Summarise clinical trial data and analyse and interpret clinical data, discussing results with internal teams and KOLs Liaise with vendors/external contractors as assigned; ensure timelines and quality of product when the writing of a document is outsourced Mentor, coach, and/or otherwise assist in the training and development of other medical writers Contact:
Susan L Valdes
Principal Staffing Consultant
BioTech Resources LLC
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Biostatistician Irvine, CA |
Responsibilities may include:
Participate in planning and execution of statistical tasks for clinical studies.
Advise team members in drug development strategies.
Plan all aspects of data analysis for assigned projects.
Ensures consistency in statistical methodology, programming standards, and data specifications with all studies in the same project.
Review specification documents in data collection, integration, and clean-up to ensure quality of data.
Other duties, as assigned.
Education and/or Experience:
2 years of pharmaceutical experience with a master's degree or master's degree equivalent.
No pharmaceutical experience with a PhD or equivalent.
Knowledge and experience in computing tools, such as SAS.
Statistical technical expertise including methodology, analysis, and design.
Knowledge of global regulatory guidance documents and requirements.
Statistical expertise with regard to clinical studies on design, analysis and/or methodology.
Contact:
Lewie Casey Talent Manager Med Exec International & RxResearch Staffing 100 North Brand Blvd., Suite 306, Glendale, CA 91203 Phone: 818-552-4173 Email: lcasey@medexecintl.com |
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Technical Writer Irvine, CA |
Responsibilities may include:
Write and edit SOPs and technical documents
Review and summarize reports for clinical and regulatory filings
Integrate various sources of information into a uniform style and language for regulatory compliance.
Write SOPs, technical reports, PDSs, and PDRs
Draft method development studies and reports
Draft and update information for oral presentations
Review the accuracy of data generated
Other duties as assigned
Education and/or Experience:
BS/BA Degree
5-8 years of relevant experience in a biologics or pharmaceutical company
Experience with Microsoft Office (Excel, Word, PowerPoint) preferred
Must have ability to read, analyze, and interpret the most complex documents in English
Contact: Lewie Casey Talent Manager Med Exec International & RxResearch Staffing 100 North Brand Blvd., Suite 306, Glendale, CA 91203 Phone: 818-552-4173 Email: lcasey@medexecintl.com |
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Senior Medical Writer, Contract Cambridge, MA |
Duration of Contract: 1 year Location: Cambridge, MA; must work on site Job Description:Prepares clinical regulatory documents (protocols, IBs, CSRs, clinical summary documents) with minimal supervision Represents department on clinical teams; leads document-related meetings Able to analyze data. Has strong communication, organizational, and meeting skills Contact:Amy E. Fink Clinical Recruiter MedFocus, LLC. 8600 W. Bryn Mawr, Suite 700 Chicago, IL 60631 O:(773) 632-1785 F:(866)439-9491 M:(847)636-0770 www.medfocus.comafink@medfocus.com |
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Medical Writer (Publications), Contract Seattle, WA |
MedFocus is currently seeking a medical writer to help our client plan and coordinate production of scientific publications (manuscripts, abstracts, posters, slide presentations) for multiple clinical development programs.
This is a 6-month contract that is extendable. Must work on-site as W2 employee of MedFocus. Responsibilities:
Participate in publication planning activities and manage multiple projects across development programs
Coordinate development of publication-ready manuscripts and presentations.
Draft and edit document sections, manage review cycles and coordinate revisions.
Collaborate on development of effective data presentations.
Prepare slide decks and poster presentations in collaboration with authoring team.
Develop and implement templates and formats to ensure that documents meet industry and editorial standards
Requirements:
This position requires a bachelor's degree in a life sciences discipline (advanced degree preferred) and a minimum of 3 years biopharmaceutical industry experience.
Experience preparing scientific publications, including summarizing and interpreting complex clinical data, is essential.
Knowledge of drug development and clinical research processes required, with oncology experience preferred.
Literature searching and reviewing capabilities also required.
Familiarity with CONSORT, ICMJE and other industry standards and journal requirements is necessary.
Must have strong written and verbal communication skills and high level of attention to detail.
Expert abilities in Microsoft Word, Excel, and PowerPoint required.
Contact:
Amy E. Fink
Clinical Recruiter
MedFocus, LLC.
8600 W. Bryn Mawr, Suite 700
Chicago, IL 60631
O:(773) 632-1785
F:(866)439-9491
M:(847)636-0770
www.medfocus.com
afink@medfocus.com |
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Medical Writer Northern NJ |
Job Description:
Research, writing and editing of regulatory documents
Provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission
Assure quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
Requirements:
Bachelor's degree and a minimum of four years in Medical Writing
Experience in Clinical and Regulatory Documents, CSRS, IBs, INDs, NDA, protocols
Excellent written and oral communication skills in English
Familiarity with all phases of medical research and ability to learn new medical concepts quickly
Familiarity with statistics and experimental design
Ability to summarize complex data and identify relationships
Contact:
Matthew Howell
Executive Search Consultant
Fidelis - Biopharm
Direct 972-770-7920
Fax 972-392-9255
mhowell@fidelisbiopharm.com |
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Senior Medical Writer Washington, DC Area |
Job Summary:
Write, edit, review, and format high-quality clinical regulatory and other supporting documents for multiple therapeutic areas
Write and edit clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents
Work with contract writers, as needed
Review clinical protocols, statistical analysis plans, statistical programming plans, data tables and listings, and other clinical regulatory documents, as needed
Lead the process of critical review of clinical regulatory documents and incorporate multiple reviews into successive drafts
Provide QC support for clinical regulatory documents, as needed
Assist with preparation or revision of SOPs, WPD, and document templates
Requirements:
MS or PhD required
6+ years experience writing clinical regulatory documents, including clinical study reports
Pharmaceutical industry experience needed
Background in biologics is a plus
Experience writing and editing ICH-compliant regulatory documents
Experience developing eCTD-compliant regulatory documents
Excellent writing, editing, verbal, and interpersonal communications skills, and strong attention to detail
Proficiency in Microsoft Office applications
Familiarity with CTD, ICH, GCP, and other standards
Contact:
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