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Job ID 218030BR Position Title WorldWide Medical Affairs Director - Ophthalmology Division PHARMA Business Unit GPS&C Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Responsible for providing medical and scientific leadership into medical brand teams and other brand related functions from pre-launch through Life Cycle Management. Global Medical Affairs (GMA) Director supports the Worldwide Brand Medical Brand Director (WWBMD) in the execution of Medical Advisor (MA) activities in alignment with GMA functions.
1. For the assigned Medical Affairs studies (Phase IIIB-IV, Publication Management System (PMS), non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the GMA Director provides medical scientific input to, e.g.:
a. Key activities related to planning, execution and reporting of Global Medical Affairs studies and ensure timely and on budget delivery.
b. Develop or contribute to study-related documents (e.g. concept sheets, protocols, case report forms, statistical plan, data analysis plan, study reports, publications).
c. Develop/contribute and review presentation materials for study/program-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and external speaker at meetings when required.
d. Ongoing review of clinical study data, final analysis and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team (GCT) members and the GBT (Global Brand Team).
e. Act as medical key contact point for assigned MA studies.
2. Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GCT, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis Country Pharma Organizations (CPOs), and other line functions within GMA and external customers e.g., Health Care Professionals (HCPs) ,Market Access and Patient Advocacy Groups (PAGs).
3. Build together with the Global Brand Medical Director (GBMD) Medical Affairs strategy
a. Provide support on the Medical Affairs Plan and other lines functions plans (Clinical Development Plan (CDP), Integrated Product Strategy (IPS), etc.)
b. Provide input on scientific content of Program/brand(s) publication plan to assigned Medical Communication Leaders (MCLs) c. Support/lead data mining and Real World Evidence (RWE) activities and support/lead process.
d. Provides medical support/ input to GBMD and to MCL or deputize in selected cases for internal and external medical education and communication initiatives (e.g., speaker training, advocacy, Medical Experts strategy, advisory boards, Medical Science Liaison (MSL) support and education, launch support, congress planning and execution). Minimum requirements MD or PhD with knowledge with ≥ 6 years of clinical research experience preferably in the Health Industry
• MD, PharmD or PhD with knowledge and experience in medical affairs activities, with ≥ 6 year
Fluent English (oral and written)
Advanced medical/scientific writing and communication skills.
• Proven ability to interpret, discuss and represent efficacy, statistical and safety data relating to the assigned area.
• Proven ability to work both independently and in a cross functional team setting, including a highly-matrixed environment.
• Demonstrated ability to establish strong scientific partnership with key investigators in assigned Therapeutic Area (TA).
• Medical and/or scientific expertise within a disease area required.