Global Submission Manager

Job description

Job Description Technical Format Expert who is responsible for leading the management, organization, assembly, production and delivery of high quality submissions (electronic and/or paper) to the appropriate Health Authorities according to upper management's target submission dates. Partners the franchises and liaises closely with associates in order to incorporate Health Authority requirements • Attends pre-submissions Health Authority (HA) meetings with the Line Functions and DRA Managers/PTL as the Technical Format expert • Provides strategic and operational expertise to project teams to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authori-ties (EMA, FDA, Swiss Medic, LATAM, ROW) • Determines requirements for Health Authority (HA) interactions with GPRD and/or GPRM • Develops and implements Technical Format requirements with other line functions, Country Pharma Organizations and key opinion leaders to provide a company business guidance on format deliverables • Works in a global capacity with colleagues in EH and India. Delegates submission tasks to Senior Publishers and publishers who are located in India • Function as the DRA Operations liaison for the project teams. Primary contact for DRA Ops for all submission related activities related to assigned projects. Provides advice and guidance to project teams regarding general content and format of regulatory submis-sions. • Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned regulatory submissions. Ensure adherence to internal standards and processes, as well as Health Authority's require-ments. • Organizes and chairs the submission tracking meetings. Owner of the submission tracking tool. • Works very closely with DRA Ops counterpart and respective DRA TA/BU manager(s) to ensure proper organization of a timely submission. Communicates openly and effectively at team meetings. • Leads DRA Ops submission team. Ensure through coordination with GLF Submission Co-ordinators (or designee) that all participants involved in the preparation of the submission receives appropriate and timely training (e.g., Novstyle, xEDI, major Health Authority Submissions regulatory requirements). Proactively tracks individual documents and sub-mission timelines. Maintains and updates submission tracking sheet along with the re-sponsible GLF submission coordinators (or designees). Partner with LF Coordinators (or designee) to negotiate every submission component target date with the goal of achieving the target submission date. Challenges submission timelines to ensure both a quality and timely delivery of submission components • Communicates openly, effectively and timely with DRA Ops counterparts on all submission issues and activities. Liaise with counterpart and applicable LFs (e.g., DiT, Clinical etc.) for problem solving (ensuring agreed upon action is implemented at the local destination). Immediately notify DRA Ops management and project teams of any issues / activities that may adversely impact the submission date. Provide status report to Submission Leader (DRA PTR) and line management within DRA. Identify issues and solutions relating to timing, quality and resources. • Organize and supervise the QC and sign-off of prepared submissions before finalizing them. Ensure proper transfer to electronic medium, paper printing or electronic transfer via the Health Authority gateway. • Provides Operational input for Health Authority submissions (e.g. Briefing books) • Contribute to continuous improvement of submission processing (e.g. assisting with the update of existing business processes, authoring of new processes etc.) and knowledge transfer within DRA Ops. Contribute to cross functional initiatives, as necessary. • Actively participates in the evaluation of new tools and technologies to ensure adherence to Health Authority requirements as well as internal standards. • Implements and deploys new processes. • Participates in other department activities / initiatives as required. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

University degree or equivalent in a scientific discipline such as biology, chemistry or pharmacy Fluency in English (oral and written). German is desirable. At least 3 years of relevant experience in managing, compiling, publishing and/or handling regulatory submissions. Detailed knowledge of the organization of Health authority submissions Strong knowledge of techniques for electronic compilation and publishing submissions. Familiar with state of the art publishing and document management software and the concepts required to produce regulatory submissions using these technologies. Effective interpersonal skills to interact with associates at various levels of the organization and external contacts Has demonstrated effective project management, teamwork, communication (oral and written) and organizational skills. Ability to lead a temporary team under the stress of short time frames Highly motivated and self-starter Solid computer technical skills (e.g. MS Office Products i.e., Word/Excel/PowerPoint, Windows XP, Lotus Notes mail, Adobe Acrobat w/plug ins, etc.) and ability to learn new systems quickly. Understanding of XML technology as applied in the field of eCTD, Structured Product Labeling (SPL) or PIM. Working knowledge of drug development, international drug registration and approval processes and related document format requirements. .