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Apply to JobJob ID246591BRPosition TitleWorldWide Medical Affairs Director RheumatologyJob DescriptionIn this role you will be responsible for providing medical and scientific leadership to medical brand teams and other brand related functions from pre-launch through Life Cycle Management. You will support the Global Brand Medical Director (GBMD) in the execution of Medical Affairs activities in alignment with Global Medical Affairs (GMA) functions.



Major accountabilities:

1. For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provide 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. On-going 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 GBMD Medical Affairs strategy

a. Provide support on the Medical Affairs Plan and other lines functions plans (CDP, 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. Provide 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).

e. The WorldWide Medical Affairs Director is the MSL point of contact with the Global Medical Affairs Team (GMAT) and is responsible for providing compound and/or disease area-related scientific training and materials to MSLs. The WorldWide Medical Affairs Director is responsible to channel the GMAT deliverables to MSLs in alignment with Regional Medical Directors/Regional Franchise Heads. The WorldWide Medical Affairs Director brings to the GMAT the medical insights gathered by the MSLs based on feedback from external stakeholders.

f. Provides the medical input to MSL materials and related activities and supports the development of these deliverables in cooperation with the MCL

4. Provide medical scientific input for the assigned program/brand(s) to:

a. Develop integrated Product Strategy (IPS), MA strategy and related MA plan

b. Develop Clinical Development Plan (CDP section related to MA activities)

c. Guide and develop local MA clinical programs and provide support in execution

d. Value dossiers and participation at payer advisory boards

e. Provide medical inputs to prepare Global guidance documents.

f. Provide medical/scientific support for Medical Science Liaisons (MSLs)

g. Provides medical input in Periodic Safety Update Reporting (PSURs) and Development Safety Update Reporting (DSURs).

5. Support WWBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities.

6. Deputize for the WWBMD in Global Clinical Team (GCT), Global Project Team (GPT), Global Brand Team (GBT), Clinical Development Unit (CDU), CPO WebEx Alignment meetings and internal decision boards as the Medical Affairs advocate.

7. Contribute to talent and career development of MA and Development colleagues like MCLs, Field Medical Experts, and Clinical Trial staff, through active participation in on-boarding, training and mentoring activities.Minimum requirementsEducation:

• MD and/or PhD with ≥ 6 years of clinical research experience preferably in the Health Industry and preferably in relation to Rheumatology.

• MD, PharmD or PhD with knowledge and experience in medical affairs activities, with ≥ 6 years of clinical research or Global Medical Affairs experience required, preferably in the Health Industry. Previous industry experience preferred.

Or

• MD with specialty with board certification (Rheumatology or Immunology) or equivalent, with ≥ 3 years of clinical research experience.



Languages:

• Fluent English (oral and written)



Professional skills & experience:

• 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 TA.

• Medical and/or scientific expertise within a disease area required.DivisionPHARMABusiness UnitGLOBAL MEDICAL AFFAIRSLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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