Date Listed: 6/25/2008 .
Job Type: Full Time .
Hourly: Not Specified .
Degree Required: Bachelor of Science .
General Comments: .
Senior Medical Writer Job Description: With minimal supervision plan and prepare a variety of clinical documents to support all phases of clinical drug development. WORK with clinical team members to achieve consensus on document content. Participate on all levels of project-related teams, as appropriate. Represent the department AT meetings, participate in process improvement initiatives and assist supervisor as needed to support medical writing needs and achieve company goals. • With minimal supervision, plan and prepare a variety of clinical documents (Clinical Study Reports, Investigator’s Brochures, Protocols, IND Annual Reports, Manuscripts, Abstracts, Slide Presentations and other regulatory submission documents) by organizing, analyzing, interpreting and presenting scientific, clinical and statistical data. In coordination with other clinical and project team members, develop key study and product related messages. • Conduct document-related meetings to achieve consensus on content among clinical team members and obtain approval of documents within timelines set by supervisor. • Documents are to be of high quality, scientifically accurate and reflect a consensus among team members that is acceptable to all reviewers. Ensure that documents meet all company and other regulatory guidelines (eg, ICH and eCTD). Prepare documents in accordance with established internal procedures (ie, SOPs). • With general supervision and in coordination with the dossier planning team, plan and prepare regulatory summary documents (eg, Clinical Summary, Clinical Overview, etc.) for eCTD product license applications (ie, NDA, MAA, etc). • Participate on clinical program teams and clinical action teams, as appropriate. Represent the medical writing department AT clinical and/or interdepartmental meetings as well as on process improvement committees. • Review documents of other writers, as needed, to provide input on quality and content. Oversee document preparation by outside vendors and freelance contract writers, as appropriate. Screen, select and manage vendors for writing assignments. • Acquire and maintain expertise in therapeutic areas of interest by reviewing current literature and attending scientific meetings. Acquire and maintain a strong knowledge of regulations (ICH, 21 CFR, etc) governing regulatory submission documents. Documents are to be of high quality and scientifically accurate. Ensure that documents meet all internal and other regulatory guidelines (eg, ICH and eCTD). Prepare documents in accordance with established NPS procedures (ie, SOPs). • Develop and maintain departmental document repository. • Assist supervisor with other departmental projects, as required. The job consists primarily of office-based WORK. Occasional travel to off-site meetings may be required (WORK for a minimum period of 6 months, the senior medical writer may fill out an application to WORK FROM HOME no more than 2 day per week, in accordance with the company policy. Basic Job Requirements Education: AT minimum, the job requires BS + 5-7 years, MS + 6 years, PhD/PharmD + 4 years previous technical or pharmaceutical industry experience. Degree in scientific discipline highly preferred. Experience: Previous experience in scientific or medical writing, in particular with regulatory submission documents, is required. Specific skills: The ability to accurately and clearly present clinical and scientific data as well as strong verbal, written and interpersonal communication skills is also required. Specialized knowledge, Licenses, etc.: Thorough understanding of global pharmaceutical regulatory requirements and knowledge of the clinical research process required. A basic working knowledge of statistics and statistical terminology is required. A strong working knowledge of MS Word, Excel and PowerPoint are required. Knowledge of Documentum and/or publishing software is a plus.
Applicant Category: Professional
Requisition Code: Work at home
Two Initials of Recruiter: bw
System Date: 07/01/2008
System Time: 05:48:22
Document Name(40): Senior Medical Writer
Source: www.CareerMarketplace.com - USA
SearchTerms: "work at home" "work from home"
URL(80): http://www.careermarketplace.com/jobseeker/sDetail.asp?JobAdID=146143&RunSearch=
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