Sr Document Review Spec

The Senior 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 advent narratives, study protocols, case report forms, and publications (manuscripts, posters, abstracts).The Senior 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 Senior Document Review Specialist brings to the review a comprehensive knowledge of clinical research, PPD procedures, English grammar, diverse therapeutic areas, experimental design, and regulatory requirements.The Senior 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 advent narratives, study protocols, case report forms, and publications (manuscripts, posters, abstracts).The Senior 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 Senior Document Review Specialist brings to the review a comprehensive knowledge of clinical research, PPD procedures, English grammar, diverse therapeutic areas, experimental design, and regulatory requirements. Education and Experience:Bachelor's degree3 years experience in pharmaceutical/medical device industry including experience with regulatory submissions6 years of relevant 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 conceptsAbility to interpret clinical data and to guide others in their presentation of clinical informationExcellent problem-solving capabilities and organizational skills and effective interpersonal skillsExcellent grammatical and communication skills, both written and oralExcellent editorial/proofreading skills and understand and perform well the process of writing, reviewing, and editingExtensive knowledge of the methods, techniques, and procedures of medical writing tasksDetail-oriented, thorough, and methodicalAbility to create and follow timelines and do long-range planningAdaptable to changes in work duties, responsibilities, and requirementsAbility to apply appropriate judgment regarding changes and final determinations in the presentation of data in accordance with regulatory guidelines and reviewers' commentsAbility 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 ExcelAble to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variablesAble to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining resultsAble to initiate work and to motivate othersAbility to act independently to determine methods and procedures on new assignments and supervise the activities of other personnel 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 degree3 years experience in pharmaceutical/medical device industry including experience with regulatory submissions6 years of relevant 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 conceptsAbility to interpret clinical data and to guide others in their presentation of clinical informationExcellent problem-solving capabilities and organizational skills and effective interpersonal skillsExcellent grammatical and communication skills, both written and oralExcellent editorial/proofreading skills and understand and perform well the process of writing, reviewing, and editingExtensive knowledge of the methods, techniques, and procedures of medical writing tasksDetail-oriented, thorough, and methodicalAbility to create and follow timelines and do long-range planningAdaptable to changes in work duties, responsibilities, and requirementsAbility to apply appropriate judgment regarding changes and final determinations in the presentation of data in accordance with regulatory guidelines and reviewers' commentsAbility 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 ExcelAble to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variablesAble to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining resultsAble to initiate work and to motivate othersAbility to act independently to determine methods and procedures on new assignments and supervise the activities of other personnel 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.