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Company Jobs - International Partnership for Microbicides, Inc.


 

Manager, Regulatory Affairs

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 and Experience Education and experience equivalent to a Bachelor’s Degree in public health, microbiology, clinical science or material science disciplines. 7+ years’ experience in drug regulatory affairs CMC regulatory experience a plus Knowledge, Skills and Abilities Working knowledge of US and international regulations for drug development Ability to analyze and interpret regulatory documents Excellent technical skills, including experience with electronic publishing software and document management technology Excellent organizational skills Excellent written and verbal communication skills Well-developed analytical skills Knowledge of scientific principles and terminology / scientific background required Ability to work in a fast-paced environment and manage competing tasks and demands Terms and Conditions Position located at Headquarters in Silver Spring, MD. Job holder should expect fast-paced working environment. Willingness to travel as needed. IPM is an Equal Employment 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. 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 - 4/17/2015 8:56:32 AM

Director, Regulatory Affairs

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 and Experience Education and experience equivalent to a Bachelor's or Master’s Degree in public health, microbiology, clinical science or material science disciplines. 10 years of related experience, (3) three years supervisory experience preferred Experience with Regulatory policy and procedure development Domestic and international regulatory compliance and submissions/approvals experience Knowledge, Skills and Abilities Results orientation - ability to work in a fast-paced environment and meet deadlines with competing priorities Creative, constructive, responsive approaches to multiple expected and unanticipated challenges of complex regulatory filings with several national regulatory authorities. Demonstrated ability to orchestrate complex relationships among organizations and individuals and to interact effectively with regulatory agencies, clinical investigators and site staff, clients, colleagues, supervisors, subordinates, and the public. Excellent organizational, planning, negotiating, and problem-solving skills. Cultural sensitivity. Detail-oriented while keeping the big picture and long-term goals in perspective. Clear, concise, effective verbal (technical and interpersonal) and written (administrative and technical) communication. Strong self-management skills with a high level of initiative, creativity, and assertiveness. Ability to work independently yet cognizant of her/his role as a representative of, or spokesperson for, the IPM. Goal-oriented, collaborative team player. Flexible, adaptable, and tolerant of some ambiguity; and capable of working well under pressure. Terms and Conditions Position located at Headquarters in Silver Spring, MD. Job holder should expect fast-paced working environment. Willingness to travel as needed. IPM is an Equal Employment 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. 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 - 4/17/2015 8:54:26 AM

Director, Manufacturing Sciences

London Buckinghamshire

Job Specifications Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities: Education/Experience A BS/BSc in Engineering, Pharmacy, Chemistry or related science required 15+ years relevant experience, or MS/MBA plus at least 10 years relevant experience, is preferred. Knowledge, Skills, and Abilities Candidates must have a thorough knowledge of cGMPs, and experience with the drug product manufacturing environment. Familiarity with drug product development, process validation, product launch, DOE and statistical procedures, and lean/six Sigma manufacturing. Able to lead and work effectively with cross functional teams successfully influencing other internal and external groups. An understanding of internal and external business drivers and their impact on the design and development of Pharmaceutical manufacturing processes. Technical mastery in process design or closely related work areas, with at least 10 years proven leadership capability. Experience of Project Management is also desirable. Proven ability to take the initiative and deliver results with enthusiasm and a sense of urgency, sometimes working to challenging time scales. Outstanding level of competency in problem solving and understanding processes thoroughly by applying fundamental engineering and scientific principles. Terms and Conditions Position is ideally located in Europe but US based personnel will also be considered as an option for suitably qualified staff. Role requires extensive worldwide travel to Contract manufacturing sites. IPM is an Equal Employment 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. IPM has the right to revise this job description at any time.

Posted On - 4/15/2015 7:56:04 AM

Biometrics Specialist

Paarl Province of the Western Cape

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

Paarl Province of the Western Cape

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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