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Senior Healthcare Document Publisher

Location
Newton, MA

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Job Description:
Our Client is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
SUMMARY:
The Senior Associate, Regulatory Operations is responsible various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Under the direction of the Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs and related amendments/supplements in eCTD format.  The successful candidate will ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines. This role will coordinate and liaise with external submission vendors to manage submission compilation, validation and dispatch.
RESPONSIBILITIES:
Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)
Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates
Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required
Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
Perform U.S. and international regulatory research tasks as related to Regulatory Technology and Operations
Attending internal team meetings to collect and organize potential upcoming publishing and submission tasks
Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
Participate in creation, review and implementation of department SOPs, WIs, guides and checklists
Special projects related to submissions metrics in the form of tracking, collating, analyzing and reporting of key submission statistics
Support ongoing eDMS reconciliation activities
Help drive eDMS initiatives, functionality testing and training efforts
Assist with other Regulatory and adjacent technology projects, as required
QUALIFICATIONS:
5 years of direct Regulatory Operations experience publishing, compiling, QC, Validating and coordinating electronic submissions
Electronic document publishing and eCTD experience is required
Microsoft Office Suite (key focus on Word, Excel and PowerPoint and Visio, Adobe Acrobat, TRS Toolbox (formerly ISI), archiving/ filing/RIM activities, Veeva Vault and authoring template experience highly desired
eCTD viewing, validating, and general regulatory submission project management experience preferred
Excellent verbal and written communication skills required
Ability to work in a fast-paced environment that is primarily timeline-driven
Ability to independently complete complicated and technical tasks using sound judgement within stated request period as well as work as part of a team environment
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Our Client is a clinical-stage pharmaceutical company focused on the discovery
and development of novel first in-class drugs directed against nuclear transport targets for
the treatment of cancer and other major diseases.
SUMMARY:
The Senior Associate, Regulatory Operations is responsible various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Under the direction of the Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs and related amendments/supplements in eCTD format.  The successful candidate will ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines. This role will coordinate and liaise with external submission vendors to manage submission compilation, validation and dispatch.
RESPONSIBILITIES:
Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)
Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates
Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required
Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
Perform U.S. and international regulatory research tasks as related to Regulatory Technology and Operations
Attending internal team meetings to collect and organize potential upcoming publishing and submission tasks
Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
Participate in creation, review and implementation of department SOPs, WIs, guides and checklists
Special projects related to submissions metrics in the form of tracking, collating, analyzing and reporting of key submission statistics
Support ongoing eDMS reconciliation activities
Help drive eDMS initiatives, functionality testing and training efforts
Assist with other Regulatory and adjacent technology projects, as required
QUALIFICATIONS:
5 years of direct Regulatory Operations experience publishing, compiling, QC, Validating and coordinating electronic submissions
Electronic document publishing and eCTD experience is required
Microsoft Office Suite (key focus on Word, Excel and PowerPoint and Visio, Adobe Acrobat, TRS Toolbox (formerly ISI), archiving/ filing/RIM activities, Veeva Vault and authoring template experience highly desired
eCTD viewing, validating, and general regulatory submission project management experience preferred
Excellent verbal and written communication skills required
Ability to work in a fast-paced environment that is primarily timeline-driven
Ability to independently complete complicated and technical tasks using sound judgement within stated request period as well as work as part of a team environment
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