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Company Jobs - International Partnership for Microbicides, Inc.


 

Biometrics Specialist

Silver Spring MD

Job Specifications Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities: Education/Experience Relevant tertiary education; Proven experience in data management, biostatistics and medical and regulatory writing and editing Experience with regulatory documents for a pharmaceutical company or clinical research organization Must be familiar with and up-to-date on regulations, such as ICH guidelines, and current good clinical practices Must have experience and significant participation in preparation of clinical documents for regulatory submissions Experience in incorporating diverse feedback into a high quality document Knowledge, Skills, and Abilities Exceptional attention to detail Excellent verbal and written communication skills Demonstrate expertise with grammar, syntax and format Systematic, methodical and process-driven Ability to work precisely according to procedures, rules and regulations Ability to approach issues from a number of perspectives, summarizing data to draw a conclusion Ability to work unsupervised, taking responsibility for own actions Proficiency in word processing systems, i.e. Microsoft Word (MS Office) or similar systems Results orientation - ability to work in a fast-paced environment and meet deadlines with competing priorities The International Partnership for Microbicides, Inc. is an Equal Opportunity Employer. This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned as appropriately delegated. IPM has the right to revise this job description at any time.

Posted On - 3/25/2015 8:12:12 AM

Quality Management and Compliance

Silver Spring MD

Job Specifications Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities: Education/Experience Minimum of a Bachelor’s degree or equivalent in a related discipline (including but not limited to Health, Medical, Nursing, and Biomedical science) A minimum of 3 years’ experience in Clinical Research and/or Laboratory setting Knowledge, Skills, and Abilities In-depth knowledge of GXP regulations and guidelines, the drug development process and the associated regulatory environment Experience of the overall drug development process including but not limited to Clinical Monitoring and/or Bio-analytical Laboratory operations Familiarity with HIV/AIDS and/or medical settings in Africa Experience with QA activities including audits of Research Centres, systems and vendors and audits of regulatory submissions will be considered and advantage Good interpersonal skills, including demonstrated poise and maturity in communicating with high level executives Ability to establish and maintain effective working relationships with co-workers, both within QM&C and across departments in IPM, and representatives from outside organizations Strong verbal and written communication skills with demonstrated ability to communicate effectively The position is results oriented, and requires the ability to work in a fast-paced environment and meeting timelines with competing priorities. Excellent time management and organizational skills, with demonstrated ability to organize and prioritize multiple projects and tasks Superior ability to pay attention to detail; is thorough when performing tasks and conscientious about every aspect of the work Highly motivated and team oriented, but also able to work independently Advanced computer literacy, including demonstrated proficiency of word-processing, spreadsheet and presentation applications Terms and Conditions This position is based in Paarl, South Africa, with domestic and international travel required. This job description should not be construed to imply that these requirements are the only standards for the position. Other duties may be assigned. IPM has the right to revise this job description at any time. IPM is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and IPM.

Posted On - 3/24/2015 8:02:19 AM

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