To plan and coordinate tasks supporting the timely delivery of high quality documents for sNDAs/Type II Variations or non-complex NDAs/MAAs to Health Authorities (HA) and for related follow-up activities (e.g. 120-Day Update Reports (120DUR), Answers to HA Questions), as well as to manage the logistical aspects of building the clinical sections of a submission dossier.
1. Function as submission expert for the Oncology Business Unit (OBU). Primary contact for operational submission related activities for assigned brand(s).
2. Responsible for all activities related to the development and internal approval of high quality submission documents (e.g. SCS, SCE, CO, 120DUR, etc.) in collaboration with the CPL/BSL who retains the accountability. These activities are performed according to internal and external guidelines, strategic timing and brand's development plan and strategy.
3. Write/edit documents for submissions (e.g. Answers to HA Questions, Risk Management Plan).
4. Participate in cross-functional coordination within the clinical submission team in collaboration with the CPL/CIL. Organize the dossier preparation meetings and the regular clinical submission team meetings. Communicate status report within and outside OBU.
5. Participate in activities for identifying the clinical components of the submission (e.g. list of studies, list of documents) in collaboration with the DRA manager and CPL. Organize preparation, review and approval of clinical documents.
6. Develop, negotiate and track timelines, accountabilities and responsibilities for clinical components of submission by partnering with CPL, DRA Manager, PJM and other line functions within CD&MA and OBU (DOC, B&SR, IMS). Ensure delivery of documents according to Novartis processes and defined timelines.
7. Identify issues and resource gaps for the preparation and delivery of the different documents; ensure resolution of issues including anticipation, negotiate and implement solutions in collaboration with CPL/CIL.
8. Contribute to inter- and cross-unit fertilization of other clinical documents (e.g. Protocols) by providing operational consistency.
9. Contribute to continuous improvement of submission processing and knowledge transfer within OBU. Contribute to cross-functional initiatives; serve as author or reviewer for clinical SOPs.
Advanced degree or equivalent education/degree in life sciences/healthcare is required.
Fluent English (oral and written).
• = 5 years experience in clinical research with proven proficiency in global development.
• Previous successful experience in at least one submission.
• Solid leadership talent and advanced negotiation skills.
• Proven ability to work on cross-functional teams. Has demonstrated teamwork, communication and organizational skills. Works effectively and is able to establish relationships with other line functions.
• Excellent knowledge in worldwide regulatory requirements for drug registration.
• Good verbal and written communication skills.
• Demonstrated medical writing skills.
• Global, cross-cultural perspective and customer orientation.