Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
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Qualifications / Skills Required
1) Knowledge of diagnostic imaging field and techniques, including competitive drugs and devices (Board Certification in Radiology preferred)
2) Knowledge of National and International Clinical Trials Regulations (ICH-GCP)
3) Scientific relationship with KOLs and key customers
4) Organizational awareness and accountability/ownership to achieve objectives
5) Ability to perform each essential duty satisfactorily
6) Excellent communication, presentation, Strategic vision and planning skills
7) Good spoken and written English
8) Project management and leadership skills
9) Willingness to travel, domestic and International
Job Description
Print Job Description
Partial Job Description 1) Provide directions and support for development of new products (contrast agents and devices), for new indications for marketed products and lifecycle medical management activities 2) Provide medical directions and support for Phase I-III clinical trials and market studies (Phase IIIb-IV) as required, based on imaging and product requirements 3) Provide medical support to Regulatory Affairs, including preparation of regulatory documents for new and established products 4) Provide support to medical operations, including input for selections of investigators, scientific and medical support for investigator meetings and investigator training sessions, medical support in regards to safety and efficacy issues that arise during conduct of pre-approval Phase I-IIIa studies, medical input and review of statistical analysis plans, TLFs and final reports 5) Support marketing specific needs upon request (i.e. scientific support for the preparation and content review of promotional material) 6) Support medical communications division in planning strategic communication and review scientific documentation, including manuscripts and abstracts, as required 7) Present effectively clinical data internally and at international meetings 8) Build strong internal network as credible partner and expert in diagnostics area and external relationships in product areas and contribute to the development and maintenance of clinical and medical strategies for diagnostic imaging products 9) Develop and support the preparation of guidelines in regards to the use of marketed products 10) Design, plan and manage clinical development projects (Phase I-III clinical trials), including preparation of protocol outlines,support for preparation and review of study-related documents such as Clinical Trial Protocols (CTPs), Case Report Forms (CRFs), blinded read methodology, Statistical Analysis Plans (SAPs), Table, Listing and Figures (TLFs), Clinical Trial Reports (CTRs) and input to the selection of investigators 11) Design, plan and manage marketing support projects (Phase IIIb-IV clinical trials), including support for preparation and review of study-related documents such as protocols, CRFs, blinded read methodology, SAPs and CTRs, and input for the selection of investigators, as required 12) Provide medical support for regulatory filings (INDs, NDAs, sNDA, CTD, meeting packages) for new products or new indications of current products 13) Advice scientific global investigator initiated studies committee (GIIRC) to review worldwide proposals and provide and administer research grants, supporting independent investigators to perform research on marketed products 14) Prepare and participate in interactions with regulatory authorities, i.e. meetings, T-cons, V-cons 15) Review scientific/medical content of promotional material for accuracy 16) Prepare and deliver scientific presentations to internal and external customers in regards to current products 17) Collect information containing relevant, accurate and usable strategic intelligence about innovative technology, trends, capabilities and intentions 18) Develop medical communication strategies 19) Prepare and review abstracts, publications, presentations and documents containing evidence required to prepare guidelines concerning the use of company products, to obtain adequate reimbursement for company products 20) Perform other duties as assigned
