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Senior Medical Writer
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Senior Medical Writer .
Company: MedFocus Pharmaceutical Research Opportunities; Location: Rochelle Park, NJ 07662 .
Salary/Wage: 60.00 - 85.00 USD /hour; Status: Full Time, Employee .
Job Category: Biotechnology and Pharmaceutical; Relevant Work Experience: 5+ to 7 Years .
Career Level: Experienced (Non-Manager); Education Level: Master's Degree .
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Job Description .
SENIOR MEDICAL WRITER needed in Northern New Jersey!
Telecommuting possible - work from home 2-3 days per week, but must be available and local to office for occasional meetings
MAJOR ACTIVITIES AND RESPONSIBILITIES
Independently prepare and compile clinical documentation including clinical study protocols, clinical study reports, and summary documentation as indicated by ICH guidelines; and a variety of other documents including journal articles, literature reviews, poster presentations, and product monographs according to sponsor and/or other specified guidelines;
Prepare all documentation in compliance with project specific timelines;
Develop and maintain standards for format and content of clinical documents including clinical study protocols and clinical study reports (ie, working templates to be used when no sponsor template is provided);
Contribute to the review of documents prepared by entry and intermediate level Medical Writers and to the QC of all departmental documents (to be conducted in parallel with QA document review);
Participate in document review meetings and other project-related discussions; and
Maintain records of project-specific work hours for cost-tracking and budgeting considerations.
POSITION REQUIREMENTS
Minimum MS degree (PhD or higher preferred) in a biological science or science-related field (eg, nursing);
Five years or greater of medical writing experience in a pharmaceutical or clinical/contract research organization, including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA-required regulatory documentation (eg, pharmacokinetic and toxicology summaries and investigator brochures;
Flexibility in work schedule to accommodate project timelines.
Desirable: Previous hands-on clinical experience, eg, clinical laboratory, nursing, etc.
The Senior Medical Writer is involved in making determinations regarding the relative importance of information, clarity, logic, and order of presentation, according to medical and regulatory requirements, all of which must be thoroughly understood. This responsibility also often entails discussion and negotiation with representatives of other departments within and/or within the sponsor organization . The Senior Medical Writer makes commitments to document completion dates, following preparation and discussion with his/her manager. The Senior Medical Writer must act as an advisor to the more junior members of the department by aiding in the determination of appropriate format, emphasis, and interpretation for statistical data. The required insight should be the product of extensive experience gained from the preparation of generalized documentation and/or through expertise in various therapeutic disciplines. The Senior Medical Writer maintains a close relationship and assists the Manager in elaborating on and in explaining specific assignments with comprehensive instructions.
The Senior Medical Writer draws upon a number of sources of information, including, but not limited to: biostatistical reports, clinical input, data listings, marketing position, and regulatory requirements. Thus, it is required of the Senior Medical Writer to coordinate both information and personnel in order to ensure that all of the appropriate information and interpretive input are available for inclusion in the numerous documents derived from that information. This involves collection, synthesis, and interpretation on an inferential and descriptive level. This process requires organizational cognitive skill in order to arrive at a final presentation that conveys what is necessary and sufficient to gain regulatory approval for submission documents or acceptance of journal articles for publication.
GUIDELINES UTILIZED:
Code of Federal Regulations [21 CFR] and Guidelines: The standards and requirements promulgated by the Food and Drug Administration (FDA) with regard to the conduct of research and the content and format of submission documentation. The documents are submitted in support of applications to conduct clinical research (Investigational New Drug [IND] applications), to market drugs (New Drug Application [NDA] or Common Technical Document [CTD]), as well as to supply ancillary information.
European Economic Community Guidelines: These provide the stipulations and regulations regarding submission to the European Economic Community (EEC) countries
Guidelines for Common Technical Document:: These provide for the format and content of documentation considered to be acceptable for submission to the FDA and to the EEC.
AMA Style Guide: This is a compendium of accepted grammatical and stylistic principals.
Required formats for publication of manuscripts: Specific format requirements for particular journals to which manuscripts may be submitted for publication.
Previous regulatory submission, publications, and documentation that have been well-received/approved: Historical documents provide useful models upon which subsequent ones may be constructed.
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Learn more about MedFocus Pharmaceutical Research Opportunities .
Applicant Category: Professional
Requisition Code: Work at home
Two Initials of Recruiter: bw
System Date: 09/12/2007
System Time: 08:56:38
Document Name(40): Senior Medical Writer
Source: Monster.com - USA
SearchTerms: "work at home" "work from home"
URL(80): http://jobview.monster.com/getjob.asp?JobID=62249554&JobTitle=Senior+Medical+Wri
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