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| 23 July 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 20 |
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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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Associate Director, Regulatory Medical Writing Philadelphia PA Area |
A growing biopharmaceutical company in the Philadelphia region is looking for an Associate Director, Regulatory Medical Writing to work within their Worldwide Clinical Research Department. The Associate Director, Regulatory Medical Writing provides technical and editorial expertise and administrative guidance to medical writers within the Worldwide Clinical Research Department with regard to regulatory document preparation processes, standards, quality, and timeliness in support of drug development, product registrations, and product marketing.
Essential Areas of Responsibility:
1. Provides technical expertise to writers in the use of document templates and other tools for the preparation of regulatory documents to ensure adherence to relevant standards and applicable regulations and guidelines.
2. Provides editorial expertise to writers in the preparation of high quality regulatory
documents to ensure both high editorial quality and adherence with agreed writing
standards.
3. Provides administrative guidance to writers to ensure that standard processes and accepted practices are followed with regard to developing schedules and the overall preparation of documents.
4. Develops and maintains document templates and guidance documentation.
5. Works with writers and quality control (QC) staff to schedule document QC according to agreed time lines, and manages the QC workload.
6. Works with writers and Clinical Quality Assurance (CQA) to schedule document audits
according to agreed time lines.
7. Performs macro-editing of documents for organization, content, structure, and tone, and to ensure documents are consistent within clinical programs, and micro-editing of documents for punctuation, grammar, sentences, paragraphs, and writing styles.
8. Critically reviews regulatory documents for content for comprehension and to ensure
inclusion of clear and consistent messages.
9. Represents Regulatory Medical Writing on interdepartmental projects and initiatives within the company.
10. Prepares regulatory documents as a senior contributor.
11. Maintains professional knowledge by affiliating with professional organizations, attending conferences and seminars, and reading applicable literature and regulatory guidance documentation.
Provides technical and editorial expertise, globally, to Regulatory Medical Writing in support of the overall departmental goals, as indicated by:
· Overall document technical and editorial quality, timeliness, and consistency in regulatory
documents within and across clinical programs
· Use of standard processes and agreed practices in the preparation, scheduling, and delivery
of regulatory documents
· Up-to-date document templates and guidance documentation
· Smooth document work flow through QC and CQA steps
· Knowledge of global regulatory requirements for clinical documents
Minimum Qualifications:
This position requires (1) superior communications, interpersonal, organizational, and problemsolving skills, and document planning and preparation skills (2) expert competency in relevant software applications and using templates and electronic formats, (3) a thorough understanding of government regulations pertaining to drug development and the drug development process, (4) an excellent understanding of the Company's products and SOPs, and (5) exceptional ability to manage multiple priorities and work well under time constraints. Demonstrated medical/technical/regulatory writing ability and a BS or BA in a scientific/medical/communications discipline with a minimum of 10 years of medical writing/communications work experience, an MS or MA with a minimum of 7 years of relevant work experience, or a PhD with a minimum of 5 years of relevant work experience.
Contact:
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Senior Medical Writer Florham Park, NJ |
Permanent position
Responsibilities:
Write, review, format and finalize complex clinical documents including trial related documents and submissions to Regulatory Agencies.
Work within a cross-functional team of physicians, statisticians, regulatory and clinical development staff to prepare protocols, clinical study reports, safety and efficacy summaries, investigational drug brochures, sections for IND/IDE applications, clinical sections of regulatory submissions, manuscripts, and external and internal presentations.
Provide editorial and quality control reviews of clinical documents prepared by others, emphasizing the accuracy of information as well as consistency with regulatory guidelines and requirements.
Assist with the development of the informed consent, manual of operation prototypes in conjunction with the clinical trial team.
Create and maintain clinical document templates in accordance with regulatory guidelines and requirements
Research and summarize relevant literature references. Implement and monitor adherence to standards, processes, and procedures.
Maintain up-to-date knowledge of standards and procedures for clinical and regulatory documents (including eCTD) in the US, Europe, and other countries.
Contribute to the review and development of existing and new Clinical Operations SOPs as they relate to medical writing functions.
Qualifications:
BS or equivalent required. Advanced degree in a relative scientific discipline is preferred.
Minimum of 5 to 7 years medical writing experience supporting clinical development activities within the pharmaceutical/biotech industry along with the interest and ability to work under tight deadlines while coordinating multiple projects.
A collaborative working style, superior written communication and documentation skills, and expert level proofreading and documentation management skills.
Contact:
For immediate and confidential consideration, please send a word version of your resume to ssmith@judge.com. |
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Manager, Medical Writing San Francisco Bay Area |
The Manager of Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff and may assist in the development, review, editing, and finalization of documents for regulatory submission and publications. The client has 3 marketed products, a market cap of over $2 billion, stock is near its high and they are growing!! This is a full-time, permanent position. Responsibilities:Assists with Medical Writing deliverables planning for assigned projects and programs, including resource forecasting, timelines, and budget; assists with resource allocation; monitors and reports on status of assigned projects; oversees completion of all assigned projects. Regular participant in clinical subteams as clinical/regulatory documentation specialist. Works with project subteams, management, Writing Specialists, and business partners to establish/renegotiate timelines. Ensures content and messages are consistent across regulatory documents within assigned program(s). Accountable for documentation deliverables quality and ensures work on assigned projects adheres to departmental procedures and practices and technical and industry standards Participates in the Medical Writing department recruitment process and participates in broader BioMetrics recruitment activities. Develops Medical Writing related SOPs, develops or manages development of templates, work process documents, Style Guide, or content guidelines that conform to document specifications and internal publishing requirements for regulatory filing, and contributes to developing SOPs for BioMetrics. Contributes to development and implementation of Medical Writing training curriculum. Applies adaptive mentoring and coaching practices for Medical Writers.
Education:Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Experience:At least 6 years of experience in medical writing in the pharmaceutical industry. Management: Minimum of 2 years administrative and/or functional management experience as a manager, supervisor, or team lead in a clinical development setting. Contact:
Please send a Word version of your current resume to Bonnie Gothmann at bonnie@corpsearchjmi.com, or call 415-684-1960 X 105. |
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Medical Writers Southern CA |
I have full time openings currently for medical writers in northern NJ, Pennsylvania, and NYC. All openings are expected to work on-site (no telecommuting), require PhD, PharmD, or MD Degrees and at least a year of medical writing experience for a medical communications agency.
I also have openings for associate medical directors and scientific directors--same degrees required and more years of medical writing in a med comm agency needed.
Contact:
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