Nonclinical Documentation Specialist
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POST DATE 9/8/2016
END DATE 11/19/2016
JOB DESCRIPTIONJob Description
Ensure comprehensive reviews for all types of nonclinical documentation/reports/publications, including QC and verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective for all NCD documents and regulatory submission components.
Provides support for the authoring, editing, QC, formatting, and publishing of NCD documentation and regulatory submissions in accordance with agency requirements and company standards.
Provides support for the authoring, editing, data verification, formatting, and publishing of NCD documentation and regulatory submissions in accordance with agency requirements and company standards.
Includes operational tasks associated with or in support of authoring (formatting, editing, reviewing, electronic workflow management) and ensuring submission readiness of documentation entered into the electronic document management system(s).
Ensure regulatory guidelines and internal processes are followed within established process timelines.
Assist Nonclinical Regulatory Submission team members with timeline activities and management.
Assist Nonclinical Management and leads to develop robust processes and documentation related to the implementation of projects which transition from discovery to development.
Ensure comprehensive reviews for all types of nonclinical documentation/reports/publications, including verification of all references and source data, to achieve the highest quality from technical, regulatory, and compliance perspectives for all NCD documentation and regulatory submission components.
Review, edit, and data verification of nonclinical (Toxicology, PK and Pharmacology) and bioanalytical (qualification, validation, and bioanalysis) reports, as well as other nonclinical documentation and publications in collaboration with contributing NCD staff
Ensure adherence to Regulatory and R&D Compliance guidelines, in addition to the NCD internal/external documentation review and approval processes/SOPs.
General management and adherence to established timelines and communicate to NCDRS management regarding any delay or issues with review.
EDUCATION & EXPERIENCE REQUIREMENTS:
Bachelors or higher in a relevant technical or scientific field is required.
At least 3 years experience compiling nonclinical documentation or regulatory submissions, preferably within the pharmaceutical/biotech industry is required.
Experience in a regulated environment (eg, CRO or global regulatory agency) with sound knowledge of relevant global regulatory agency regulations/ expectations and industry standards/best practices pertaining to regulatory operations and submissions is required.
Fluency in written and spoken English is required.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.