U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientific Liaison, Russian in 1, Russia

Description

Roles and Responsibilities:

  • Participates in planning the scientific review process.

  • Coordinates the scientific review workflow with external Russian-speaking consultants ; serves as a point of contact for the majority of within-country communications and interactions with contractors.

  • Independently edits and proofreads USP pharmacopeial content and any supporting documentation translated into Russian with minimum supervision to ensure scientific accuracy, quality, and clarity of the translated text.

  • Identifies potential deficiencies and suggests corrective actions for consideration by USP editorial and scientific staff.

  • Identifies errors and inconsistencies in chemical names and formulas, including those resulting from nomenclatural peculiarities of the target language, and suggests corrective actions.

  • Researches scientific and regulatory literature in Russian and English to resolve scientific and compendial language consistency issues.

  • Compiles new entries for inclusion into the English-Russian scientific glossary for subsequent consideration by USP staff and volunteers.

  • Contributes to and co-maintains the Russian Style Guide and the USP Russian Glossary.

  • Maintains the Russian Errata system and submits English and Russian errata.

  • Coordinates and leads meetings of the USP staff and relevant Russian-language associates, identifies key issues for discussion, compiles agenda and notes, and delivers presentations on assigned topics.

  • Trains Russian-speaking scientists.

  • Identifies potential scientific and regulatory content experts in relevant areas of expertise, establishes and maintains relationships, and ensures strict adherence to USP Conflict of Interest and Code of Ethics requirements.

Basic Qualifications:

  • Doctorate in Chemistry, Biochemistry, Pharmacy or related fields with a minimum of 8 years’ experience, or M.S. and 10, or B.S. and 15 years of relevant experience with following pharmacopeial regulations required.

  • 8 years of hands-on experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titrimetry, required.

  • Knowledge of compendial standards related to the pharmaceutical industry in the Russian Federation, but also in the United States, is strongly preferred, as well as knowledge of international regulatory requirements and guidelines for pharmaceutical, dietary supplement and food industries (e.g., FDA, ICH, JECFA, etc).

Preferred Qualifications:

  • Excellent written and verbal communication skills in Russian and English. An English proficiency test, with specific emphasis on scientific, analytical, pharmaceutical and pharmacopeial content may be administered, in addition to spoken English interviews.

  • Strong presentation skills, both written and oral.

  • Familiarity with and ongoing education on the normative pharmaceutical and regulatory documentation issued by the relevant United States, international and Russian regulatory agencies.

  • Ability to reconcile specialized scientific and pharmacopeial terminology in English and Russian.

  • Adequate command of chemistry, chemical nomenclature, analytical techniques, and methodologies, and understanding of basic pharmaceutical manufacturing operations.

  • Familiarity with areas of scientific knowledge relevant to pharmacopeial work including biologic drugs, excipients, active pharmaceutical ingredients, dietary supplements, analytical and pharmaceutical manufacturing instrumentation, quality control, regulatory science, basic statistics, metrology.

  • Proclivity to undertake in-depth investigations, comprehend and critically assess complex data in order to reach reliable and defendable conclusions about scientific English-Russian translated documents.

  • Ability to work in an environment guided by numerous highly technical, written requirements and instructions, closely following workplace policies.

  • Ability to maintain the work schedule accommodating the employer’s business hours, if necessary, i.e., 4PM – 1AM (MSK).

  • Ability to work independently to obtain results necessary for completing assigned tasks.

  • Ability to withstand the pressure of tight deadlines in a multi-tasking work environment.

  • Ability to efficiently communicate technical information to non-technical and non-scientific staff.

  • Excellent organizational, project management and detail-oriented skills.

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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