Document Review Spec II

The Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations. These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated clinical study reports, serious adverse event narratives, study protocols, and publications (manuscripts, posters, abstracts). The Document Review Specialist is responsible for ensuring the integrity of the data presented by conducting a timely and cost-effective review of diverse scope against client, PPD, and regulatory requirements and specifications. The Document Review Specialist brings to the review knowledge of clinical research, PPD procedures, English grammar, medicine, experimental design, and regulatory requirements.The Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations. These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated clinical study reports, serious adverse event narratives, study protocols, and publications (manuscripts, posters, abstracts). The Document Review Specialist is responsible for ensuring the integrity of the data presented by conducting a timely and cost-effective review of diverse scope against client, PPD, and regulatory requirements and specifications. The Document Review Specialist brings to the review knowledge of clinical research, PPD procedures, English grammar, medicine, experimental design, and regulatory requirements. Education and Experience:Bachelor's degree4 years of relevant experience including 1 year of experience within the pharmaceutical/medical device industry and 2 years of writing, clinical research, and editing experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Knowledge, Skills and Abilities:Excellent analytical abilityExcellent working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agenciesKnowledge of medical, pharmaceutical, and clinical research conceptsExcellent problem-solving capabilities and organizational skills and effective interpersonal skillsPossess excellent grammatical and exceptional communication skills, both written and oralExcellent editorial/proofreading skills and will understand and perform well the process of writing, reviewing, and editingExtensive knowledge of the methods, techniques, and procedures of medical writing tasks. Must be detail-oriented, thorough, and methodicalAdaptable to changes in work duties, responsibilities, and requirementsAppropriately apply judgment to making changesAbility to concentrate on the detail in a document without losing sight of the document as a whole and can perform numerous simple and complex tasks without ignoring the overall objectivesProficient with software packages including, but not limited to: Microsoft Word, WordPerfect, and Microsoft ExcelAbility to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variablesAbility to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law. Education and Experience:Bachelor's degree4 years of relevant experience including 1 year of experience within the pharmaceutical/medical device industry and 2 years of writing, clinical research, and editing experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Knowledge, Skills and Abilities:Excellent analytical abilityExcellent working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agenciesKnowledge of medical, pharmaceutical, and clinical research conceptsExcellent problem-solving capabilities and organizational skills and effective interpersonal skillsPossess excellent grammatical and exceptional communication skills, both written and oralExcellent editorial/proofreading skills and will understand and perform well the process of writing, reviewing, and editingExtensive knowledge of the methods, techniques, and procedures of medical writing tasks. Must be detail-oriented, thorough, and methodicalAdaptable to changes in work duties, responsibilities, and requirementsAppropriately apply judgment to making changesAbility to concentrate on the detail in a document without losing sight of the document as a whole and can perform numerous simple and complex tasks without ignoring the overall objectivesProficient with software packages including, but not limited to: Microsoft Word, WordPerfect, and Microsoft ExcelAbility to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variablesAbility to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.