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Senior Manager, Medical Information (MA)

The Senior Manager, Medical Information will assist the Associate Director of Medical Information in managing the Medical Information Department and its related responsibilities, including the handling of medical information requests for Company's marketed products, received from healthcare professionals (MD's, DO's, PharmD's, RPh's, RN's/LPN's, RT's, amongst others), sales representatives, consumers and others (including other Company employees). The Sr. Manager, Medical Information will assist the Associate Director of Medical Information in managing the following: Handling of all incoming medical inquiries re: any of Company's marketed products from healthcare professionals, sales representatives, consumers and others; Development of standardized responses to frequently asked questions re: any of Company's marketed products; Update of standardized responses to frequently asked questions re: any of Company's marketed products, on an ongoing basis; Handling of incoming requests from co-marketing partners (including Ross and MedPointe); Train Company Sales Representatives and other internal personnel on Medical Information and its related policies/procedures; Maintain and periodically audit the medical information database (IRMS) for tracking receipt and responses to medical information requests; Disseminate detailed periodic reports (on a weekly, quarterly and yearly basis) of medical inquiries processed by department to various internal Company employees; Develop a document management system for the most frequently utilized references; Staffing of Medical Information booth at various scientific meetings identified and management of all related activities; Perform literature searches for Company marketed products; Collate, summarize and disseminate pertinent literature to Company internal personnel and field sales force; Review competitor medical information and prepare summaries as requested; Interact with the Marketing Department (and other departments, including Sales Training) on literature dissemination to the sales force.

Minimum of a Bachelor's of Science degree in Pharmacy or Nursing. Doctorate of Pharmacy (PharmD) degree preferred. Minimum of 3-6 years within the pharmaceutical industry, with at least 2 years experience within Medical Information. For those with a PharmD degree and 1-3 years pharmaceutical experience that have completed a residency within Medical Information OR have 1 year experience within Medical Information, would be considered. Must have excellent oral, written, organizational and planning skills, be detail oriented and have familiarity with PC based applications, including Microsoft Word, Excel and PowerPoint.

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Entry level Medical Writer (NJ)-several positions
Prepare clinical study reports according to ICH guidelines; prepare regulatory summary documents such as integrated summaries of efficacy and safety, annual reports and investigator brochures; interpret statistical analyses for clinical significance; review and provide input on study protocols, statistical analysis plans, and other regulatory clinical documents such as investigator brochures and annual IND updates; write scientific abstracts, manuscripts and posters for therapeutic area conferences.

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Manager, Publication Planning (MA)
The individual in this position will supervise and coordinate the execution of the strategic Publication Plan that provides medical support to the post - marketing commercialization efforts of our products. The Manager will oversee day-to-day activities to ensure that the Publication Plan is fully integrated with the commercialization plan. The Manager will work with the Development Team (MD and PD) and the Commercialization Team (MD and Product Director/Manager), other key Team members as needed, and the Vendor managing the Publication Plan. The Manager will be responsible for: Coordinating review of key publications and other public presentation materials that are relevant to the successful marketing of our products and that are in accord with the Publication Plan and key messages agreed to by the commercialization team, including abstracts, posters, manuscripts, reviews, and slide kits to support such documents; Track receipt of comments on all materials sent for Team Review. Requirements: Minimum of Master's Degree in Science or greater and five to eight years of relevant experience. Relevant expertise in product commercialization and a "track record" of tangible success, including authorship and dissemination of data. Experience planning and completing clinical research studies is desired.

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Medical Writer (CA, MA, NJ, NY, IL)
Create necessary clinical documents such as protocols, annual reports, investigators brochures, final study reports and documents for FDA.Create document templates for clinical & research use. Revise and develop SOP's regarding clinical documents. Interface with internal and external personnel and contractors. Requirements: 3-5 years of medical writing experience in a Pharmaceutical/Biotechnology environment.

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Medical Communications Specialist (CA)
This individual will generate and communicate product and disease specific information to support the company's oncology product line; we'll rely on you to communicate timely medical information to support our product portfolio, and develop procedures for receiving, documenting and responding to product inquiries. You will develop product information responses and/or disease state related inquiries, review responses for accuracy, prepare monthly reports and identify key finds to other departments, including QA Product Support, Sales and Marketing. Additional responsibilities include reviewing literature for Sales and Marketing, assisting in sales training and literature tracking of company products, maintaining current data on cardiovascular disease and ensuring that advertising material is accurate and within FDA guidelines. Requirements: PharmD, RN, MD with 3-5 years of drug information experience.

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Associate Director, Drug Information (CA)
Sets high standards and provides guidance, direction, and leadership for the department focusing on high-quality service to both internal and external customers while maintaining and updating corporate and departmental goals. Ensures that Medical Affairs/Drug Information serves as a resource that provides timely medical, scientific, and technical information to inquiries from health and scientific professionals regarding drug related products, including complaints and adverse event reports. Ensures completeness of responses and that information is communicated professionally. Responsible for managing and overseeing the day-to-day operations of Drug Information Services (ie: tracking medical information requests in an electronic database, sending literature fulfillment requests on a daily basis, creation and/or approval of written product responses for Company's marketed products, maintenance of the current medical literature database, creation and/or approval of Educational Bulletins for the Sales Force). Additionally, responsible for establishing a strong working relationship with internal customers including Marketing, Sales, Regulatory, Legal, Quality Assurance, and Drug Safety (DS) for Company's marketed products. Responds to requests from Marketing on the medical accuracy of marketing product literature and product labeling, and that promotional and sales training materials receive thorough review in compliance with departmental, corporate, and FDA regulations. Develops and maintains the departmental SOPs and training manuals for the department. Also, responds to product recalls, participates in updating both corporate and departmental SOPs, participates in FDA audits, generates daily and monthly product reports for Sales/Marketing, generates daily product reports for DS, and gives departmental presentations when necessary. Prepares and proposes departmental budget as well as maintains the budget quarterly. REQUIREMENTS: PharmD or equivalent, with 5 years of managerial experience in drug information services in the pharmaceutical industry.

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"Without SciStaff, I would not be in my current role of Medical Director of Immunology. I have no idea how they found me but I was glad they did. The recruiter went over the details of the opportunity, gave me an in depth analysis of the client he was working and set up the interviews very quickly. I must admit that I have never seen such professionalism from any other recruiting firms as I have seen with SciStaff."

-T.E
Medical Director,Immunology
Biotechnology Firm

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