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| 23 April 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 11 |
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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 caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. | |
Senior Medical Writer Irvine, CA | |
Responsible for writing and editing key Global Safety and Epidemiology (GS&E) documents for global regulatory submissions, including Periodic Safety Update Reports (PSURs), Risk Management documents (RMPs and/or REMs), postmarketing sections of NDA/MAA/INDs, and postapproval regulatory commitments, as needed. Will work primarily with Global Safety Scientists, Global Safety Officers, and Epidemiologists to coordinate, prepare, review and format GS&E documents and reports with well-organized and effectively summarized safety information, with high quality and within predetermined timelines. The Professional will support consolidation of Team/Reviewer comments and questions and conduct data quality checks, as needed.
This position involves multidisciplinary interactions within the various functional groups of GS&E, as well as outside contributing departments, including Regulatory Affairs, R&D Clinical Development, Medical Affairs, Marketing, and on occasion Senior Management, Therapeutic Area Leads, and the Chief Medical Officer.
The Professional is responsible for tracking progress of assignments and for assisting with multiple ongoing projects. Helps implement new/modified departmental processes (SOPs, WIs, templates and forms, etc), and must operate with minimal supervision. Serve on cross-functional committees and teams, as applicable. Excellent oral and written communication skills are required, with a strong knowledge of and experience in interpreting and applying global pharmacovigilance and risk management regulations and guidelines.
Education and Experience:
An advanced degree (or equivalent experience) in health care, or other suitable combination of education and 5+ years of specific experience.
Experience preparing PSURs, RMPs/REMs, and other post marketing safety reports for regulatory agency submission.
Understanding of EU and US Pharmacovigilance, Risk Management, and post-marketing safety requirement.
Familiarity with medical terminology, and MedDRA
Responsibilities:
Actively coordinate and participate in the production of periodic and ad hoc DS medical and regulatory reports including, but not limited to, safety sections of Clinical Study Reports and health authority submissions, periodic safety update reports, and issue work-ups.
Write, edit, and coordinate production of adverse event narratives and safety-related documents.
Create and maintain departmental and safety-related document templates and controlled documents, as needed.
Proactively review and understand molecules and protocols (where applicable) that are associated with specific writing projects to facilitate efficient and effective handling of data and document structure.
Effectively communicate new developments within the regulatory writing field to internal and external groups (eg, Regulatory, Clinical Science, etc.) to ensure overall alignment with industry standards.
Participate in committees, departmental initiatives, clinical team filing activities, and special projects in collaboration with DS management.
Effectively interact on multiple projects, working independently and within intra- and inter-department functional teams.
Maintain effective communication with and influence all levels throughout a highly matrixed organization, and build successful working relationships across disciplines.
Excellent verbal and written communication skills, organizational skills, and time- and resource-management skills.
Able to effectively partner with internal and external partners in a proactive, positive, and constructive manner.
Able to manage multiple projects and timelines, and accommodate multiple priorities in a fast-paced, changing environment.
Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm.
Strong collaboration, communication, and leadership skills to effectively and clearly coordinate across multiple functional areas with a diverse group of team members.
Bachelor's degree in Science or Business-related field; clinical education and experience preferred.
Minimum 5 years of medical writing or equivalent experience.
Highly skilled in Microsoft Office applications, Adobe Acrobat, PowerPoint, and other relevant applications for writing, editing, development of controlled documents, etc.
Knowledge of biotechnology/pharmaceutical industry, the clinical drug development process, and drug safety preferred.
Knowledge of regulatory requirements and ICH Guidelines, as related to regulatory writing.
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Drug Safety Physician, Contract-to-Perm Southern CA | |
Our client is a global specialty pharmaceutical company, whose headquarters is located in California. There is an immediate need for an ON-SITE Drug Safety Physician who will be responsible for working with the Head of Safety on special projects. This position is initially a 3 month+ to perm contract. Only SENIOR Level folks should apply, and applicants must truly consider perm position.
Dress code is business casual (slacks/skirts/dresses, but no jeans, and business appropriate dress shirts, no jacket or ties required).
Full background and drug screen for contract to hire.
Required Skills:
The safety MD must have hands-on experience with
-Individual case review
-PSUR writing
-Aggregate data analysis
-Authoring response to regulatory inquiries
-Risk Management Plan
Hiring Process:
1. Initial phone screen., it will be phone and then face to face.
2. This is an initial 3-month contract that will evolve into a potential permanent role.
3. Interview ASAP
Contact:
Jessica Leveille
Manager, Biomedical Delivery Services
Orbis Clinical
100 Unicorn Park Drive
Woburn, MA 01801
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Scientific Medical Writer Northern NJ |
Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company whose purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets.
Dress code is business casual (slacks/skirts/dresses, but no jeans, and business appropriate dress shirts, no jacket or ties required).
Full background and drug screen for contract to hire. Length of Assignment:
1 year contract to perm Start Date:
As soon as possible Location:
Northern NJ , ON SITE Position:
The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. This person will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities:Assuring 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. Required Skills:
BS or equivalent, with 6 years experience in a scientific discipline and a minimum of 4 years in medical writing OR MS, PhD, or equivalent with a minimum of 2 years previous industry writing experience AND Excellent written and oral communication (English) Demonstrated working knowledge of scientific principles 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:
Jessica Leveille
Manager, Biomedical Delivery Services
Orbis Clinical
100 Unicorn Park Drive
Woburn, MA 01801
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Medical Writing Coordinator/Specialist Northern NJ |
Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company whose purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets. Length of Assignment:
1 year contract to perm Start Date:
As soon as possible Location:
Northern NJ , ON SITE Position:
The Medical Writing Specialist is responsible for tracking, quality control, and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents. This individual will not be writing the content of the submissions, but will review, edit and compile the components prior to publishing.
Responsibilities:
Work together with key interface partners (ex: Study Management, statistics, and Programming) to facilitate the completion of clinical study reports and their appendices. Using project management skills to track, review and ensure timely completion of high quality regulatory documents
Ensure the study file components needed for CSRs (ex: Investigator CVs, protocol and amendments, sample case report form) are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements
Act as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners.
Maintaining departmental and project-specific style guidelines to reflect new agreements and changes due to SOPs and regulatory guidelines
Assist scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent
Perform real-time edits to clinical documents during comment review and resolution meetings
Proofread, reformat, and edit document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation, and electronic publishing
Manage the review and approval of documents in the document management system using standard procedures
Required Skills:
BS or AS degree Strong electronic documentation and word processing skills Excellent written and oral communication (English) Excellent interpersonal skills Familiarity with clinical research, statistics, and regulatory submission requirements Understanding of regulatory guidelines (ICH, FDA, etc) Experience in a Medical Writing group would be a plus!
Contact: Jessica Leveille Manager, Biomedical Delivery Services
Orbis Clinical
100 Unicorn Park Drive
Woburn, MA 01801
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