CTG Associate Regulatory Submission Manager in Whippany, New Jersey
Title: Associate Regulatory Submission Manager
Job Number: 18203081
Associate Regulatory Submission Manager
CTG's premier global pharmaceutical client located in Whippany, NJ has an immediate need for an Associate Regulatory Submission Manager to serve as a central eSubmissions expert providing direct support to global submissions teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope.
Incumbent manages all aspects of document workflows associated with submission authoring, review, compilation, publishing and transfer on Health Registration Submissions worldwide using specialized software tools (e.g. docuBridge, documentum).
Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.
Performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types. This role includes partnering with RSMP colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.
Interprets and applies all global regulatory guidance/regulations regarding format and structure to global submissions worldwide.
Responsible for implementing and promoting global electronic submission processes and document reengineering initiatives across the organization. In addition, the incumbent will be responsible for capturing corporate knowledge regarding global submission standards and best practices across drug projects, contributing to global harmonization and transferring that knowledge to new submission teams. Knowledge transfer will include contributions to process documentation, format standards development, document template development, technical/process training.
Responsible for testing and release of new software functionality, and implementation of strategic technology initiatives related to dossier publishing.
Duties and Responsibilities:
Compiles and publishes documents/dossiers of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types.
For projects assigned, the incumbent executes all operational activities associated with compilation, publishing and distribution of submission dossiers for new and lifecycle management projects submitted to local and/or global Health Authorities. This includes collaborating with GSM colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.
Provides centralized expert support and guidance to global submission teams, internal RA stakeholders, cross-functional document authors, support staff, and publishers on the creation, preparation, tracking, publishing, QC/QA, and filing of Global submissions.
Works with submission team members to identify critical path of submission and then tracks all relevant dossier component deliverables as needed to assure timely submission of high quality dossiers.
Ensures achievement of submission milestone dates for assigned publishing support activities.
As part of the submission compilation process, coordinates the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards.
Identifies and documents issues that risk the submission timelines and escalates the issues to management to recommend appropriate resolution.
Institutes and contributes to global harmonization of QA/QC policies and procedures for Global electronic submissions and associated workflow processes. Captures corporate knowledge regarding Global submission standards and best practices across drug projects and transfers that knowledge across project teams and disciplines (via process documentation, standards development, submission document template development, technical training and process training).
Develops implements and maintains a comprehensive training curriculum associated with all aspects of the e-submission process. Acts as the Global Submissions functional area expert and lead trainer. Provides training of new and temporary Global Submissions staff as well as global project team members (cross-functional document authors).
Works with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates. Works with internal stakeholders to maintain state-of-the-art e-submission authoring tools techniques (e.g. table captioning, document styles, cross-referencing, etc.). Monitors evolving agency regulations and assures Bayer submissions comply with all document/file formats and structures.
The position functions under the direct supervision of a Regulatory Submission Lead and/or Regulatory Submission Management. Incumbent must work well with other RSMP colleagues in a global network.
Interacts with RA-managers, GRT-members and cross-functional project team members responsible for authoring of submission documents and summaries and relevant business partners incl. R&D IT functions.
Interacts with Health Authorities and responds to inquiries specifically related to the technical merit of eCTD submissions.
Educational Requirements / Qualifications / Preferences:
Minimum High School Diploma with 14 years of progressively increasing responsibilities and relevant experience. A Bachelor degree and 6 years of relevant experience is Preferred.
“Relevant experience” consists of a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs.
Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH, IBH), and regulatory guidances as they pertain to the development and filing of e-submissons. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross-functional professional staff is imperative
Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF file rendering, SAS program/transport files, XML program code, etc.).
Additionally, previous experience with a document management or electronic publishing tools is needed (such as ISI Toolbox, docuBridge etc., though docuBridge / documentum experience preferred).
Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).
Excellent verbal and written communication skills as well as interpersonal skills are needed to interact with various levels of international document authors and support staff across all disciplines.
Multi-cultural sensitivity gained from some direct international experience is highly recommended.
Ability to read and speak English fluently is mandatory.
Solid project management skills, tools & techniques, and the ability to apply these directly to managing Regulatory submission projects is mandatory.
Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential.
Compensation Range: $50.00 - $60.00 per hour (W-2)
Duration: 12 Months
Must be onsite in Whippany, NJ
APPLY NOW for resume review by Mary Jane “MJ” Slaughter or email firstname.lastname@example.org. Please reference CTG Job #18203081. Referrals are greatly appreciated!!
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Documentation Management