| February 13, 2009 | Vol. 2 No. 4 Published by Biotech Ink, LLC, and Word Angel Document Design Solutions | |
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Open Medical Writing Staff and Contract Jobs
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 If no new jobs are communicated to us in a given week, the newsletter will not be published that week. |
Senior Medical Writer
New York/New Jersey Area
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Description:Leading Pharmaceutical company in the NY/NJ area is seeking a Senior Medical Writer to write, edit and manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications. Specifically, this position will be responsible for writing summary documents for submissions (clinical safety and efficacy summaries and overviews, etc.); will help plan data analysis and data presentation used in summary documentation; will act as consultant to clinical teams to ensure documents comply with both internal company and external regulatory standards; will coordinate collaboration between the writing team and clinical team for production of the documents and submissions and ensure timely delivery of final documents for publishing; write other documents as required. Requirements: The perfect candidate would have a Minimum 4-5 years of medical writing exp. in a pharmaceutical environment. Desire a science degree or science background with strong understanding of clinical and regulatory processes. To apply please contact: Paymon Sionit Email: paymon@nsasearch.com Tel: 760-268-0390 |
Clinical Research Scientist
South SF Bay Area |
International Programming and Systems has teamed up witha Fortune 100 Medical Device company located in the South Bay and we are looking for a Clinical Research Scientist that will be involved primarily with Clinical Publications as well as Investigator Sponsored Studies. Additional information pertaining to this job is listed below for your review:
Responsibilities include:
* Interact with reviewers/approvers and external authors on project content.
* Involved in the development of tactical plans for publishing projects (ie, propose project and process improvements to appropriate staff, senior clinical research staff, medical directors, and/or marketing).
* Provide necessary clinical support for scientific and commercial organizations.
* Serve as scientific resource to sales, marketing and clinical as apporpriate.
* Present scientific evidence in support of customers developing consensus statements, guidelines, and protocols.
* Work closely with Project Management to support the Investigator Sponsored Study (ISS) programs.
* Maintain internal Clinical Publications and Investigator Sponsored Studies databases and clinical data repository through critical information data input on a consistent basis.
Goals will be accomplished by the implementation of a clinical publication strategy in concert with the business objectives of the Clinical Research, commercial organization (marketing and sales) and other appropriate internal stakeholders.
If this sounds like something that fits your background, I'd like to hear from you. My contact information is listed below and feel free to contact me at your earliest convenience.
Thank you,
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Medical Writer
Hawthorne, NY |
Acorda Therapeutics
Job Title: Medical Writer
Department: Medical Affairs
Reports To: Vice President Medical Affairs until Director, Educational Services - Medical Affairs is hired
FLSA Status: Exempt
Job Code: 0909
Summary
This position is responsible preparing scientific manuscripts, abstracts and posters. The medical writer is also, researching, summarizing data, writing and editing pre-clinical and clinical reports, summary documents, and other documents that may be submitted to the Food and Drug Administration and other regulatory bodies. Assist in the development of formats and guidelines for clinical documentation. Keep abreast of professional information and technology through conferences.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Collect and analyze references for educational programs to assure that all needs are meet.
- Responsible for the content development, writing or editing of a variety of scientific and medical documents and ensuring that they adhere to regulatory guidelines and departmental editorial standards.
- Maintain document standardization with the use of model documents or templates in order to ensure the quality of clinical project documentation.
- Responsible for the QC of documents written by other authors and clinical experts.
- Provide or assist in the management of assigned projects.
Work with internal teams to ensure that project deadlines are met, by providing content development support, research and editing functions, as required.
Education and Experience
PhD, PharmD or MD with 3-5 years medical writing experience in biotechnology or pharmaceutical industry.
Supervisory Responsibilities
None
Computer Skills
Highly developed user skills in Microsoft Office products,
Other Skills and Abilities
- Ability to proof reading their own documents for consistency and compliance with internal and external guidance documents.
- Work precisely according to procedures, rules and regulations.
- Approach issues from various perspectives and accurately summarize data to draw a conclusion.
- Superior verbal and written communication skills.
- Ability to work unsupervised taking responsibility for own actions.
- Systematically perform activities in a timely and accurate manner.
Physical DemandsNo specific physical demands Work EnvironmentNo specific work demands Best regards, Tiffany S. Corbett Manager - Human Resources Acorda Therapeutics, Inc. 15 Skyline Drive Hawthorne , NY 10532 (914) 347-4300 ext. 242 (914) 826-1729 Mobile (914) 606-9525 Fax Email: tcorbett@acorda.com Website: www.acorda.comRestoring neurological function to people with spinal cord injury (SCI), multiple sclerosis (MS) and related conditions of the nervous system. |
Clinical Scientist/Medical Writing Background
Santa Clara, CA
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Position: Clinical Scientist with Strong Medical Writing Background (Sr. Level) Location: Santa Clara, CA Duration: 24 months Pay Rate: $56-62/hr on W2 Description: Participate in writing clinical study reports; Participate in the development of study protocols, protocol amendments, clinical strategies, SOP, etc.; Support trial implementation; Prepare internal and external presentations; Interact with various study support groups, provide scientific input, and assist in project deliverables. A minimum of three years experience in medical affairs or equivalent experience within pharmaceutical or medical device settings; Strong interpersonal skills; Excellent written and verbal communication skills; Good planning and organizational skills; Excellent problem solving ability; Medical or clinical experience preferred; Post-marketing experience preferred; Proficiency in MS Word, Excel, PowerPoint MUST HAVE: Clinical Trial Experience (Preferred: Post-marketing Exp.), Experience Writing Clinical Reports, Has to be a LOCAL candidate!!!! Thanks and have a great day! Gemma Cano Technical Recruiter ACRO Service Corporation 39209 W. Six Mile Road, Ste 250, Livonia, MI 48152 Phone: 734.591.1100 x 4327 | 800.844.ACRO x 4327 | 734.542.4327 direct Fax: 734.591.1217 | Email: Gcano@acrocorp.comhttp://www.acrocorp.com/http://www.linkedin.com/in/gemmacano |
Clinical Science - Medical Writer/Sr. Medical Writer
Central NJ |
Clinical Science - Medical Writer/Sr. Medical Writer Contract is for 6+ months (3 days In-House, 2 days from Home Base Office) Permanent job (In-House 4 days, 1 day from Home Base Office) Job DescriptionResponsibilities include, but are not limited to, the authoring and editing of scientific and medical documents required during the drug development process, this includes, but is not limited to, IND, NDA and BLA sections, Common Technical Document, Investigator Brochure, Protocol, Protocol Amendments, Informed Consent Documents, integrated clinical and statistical Clinical Trial Reports, IND Annual Reports, journal articles, and abstracts and posters; preparing documents that have high quality scientific content, organization, clarity, accuracy, format and consistency with adherence to guidelines; taking an active role with respect to the planning of content, format, and timing of documents, report scheduling and tracking; providing support to the assigned clinical development team to ensure that project needs and department standards are met, while completing reports within established schedules and timelines; interacting effectively with team leaders, project physicians, statisticians, programmers and regulatory personnel, and facilitating effective interactions and information exchange/communication among co-authors/reviewers as appropriate; keeping abreast of project status, clinical operating plans and ongoing/new studies as well as scientific literature within the assigned area; maintaining/developing knowledge of regulatory guidelines, technological advances, and industry standards, and participating in other tasks as required. Required SkillsBS/BA in biology, nursing or relevant discipline; training in computer applications, GCPs, medical terminology and the drug development process. 4+ years of medical writing experience required. Must be detail oriented; possess excellent writing organizational and communication skills and the ability to work as a member of an integrated team. Experience with electronic publishing of documents an asset. Must be computer literate in MS Windows-based applications. ContactRichard Steinfeld Recruiter Fidelis BioPharm Direct Dial: 972-770-7906 rsteinfeld@fidelisbiopharm.comwww.fidelisbiopharm.com | |
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DISCLAIMER: Biotech Ink, LLC, and the Biotech Ink Insider provide the Insider jobs list on an "as-submitted basis," and neither assumes responsibility for, nor guarantees the quality or accuracy of, any listing or response. All listings are provided as a free service and courtesy to subscribers and users, and users assume all risk in using the information in the Insider.
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