Novartis Pharma
ROLE PROFILE
General Information
Title:
Organization:
Reports to:
Respiratory/COPD ERS Medical Fellow (tbc)
Global Medical Affairs
Global Brand Medical Directors (GBMDs)
Job purpose
Translate a previous experience in an academic/hospital setting into that of a Medical Team at Novartis. Responsible for providing patient centric medical and scientific input into medical teams and
other brand related functions from the start of Late Phase Development (Phase 2B/3) through the
entire life cycle. ERS Fellow supports the GBMD/GMAD in the execution of MA activities in alignment
with 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),
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. Fellow would be expect to help fully design at least one global medical affairs study across
the portfolio, including all study-related documents (e.g. concept sheets, protocols, case report forms, data analysis plan, study reports, publications).
c. Develop presentation material for study/program-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations. Speaker at scientific
meetings on behalf of Novartis.
d. On-going review and clinical monitoring of assigned 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 local medical organizations, and other line functions within GMA and external customers e.g.,
Key Opinion Leaders (KOLs) and patient advocacy groups.
3. Build together with the GBMD/Portfolio GBMD a highly influential medical and scientifically based
platform:
a.
Provide input on scientific content of Program/brand(s) publication plan to assigned Medical
Communication Leaders (MCLs)
b. Support/lead data mining activities – develop and implement specific data plans to analyze
pooled data from across the Q-family portfolio of studies (Indacaterol, Glycopyrronium and
QVA149).
ERS Medical Fellow
Final July 6, 2015
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c.
Work collaboratively with RWE Center of excellence to implement assigned COPD RWE data
generation plan, including design, analysis and publication of results. This activity could include collaboration with external/academic partners for database analysis
d. Provides support/medical input to MCL for internal (eg. Medical Teams of affiliated companies) and external medical education and communication initiatives (e.g., speaker training,
advocacy, KOL strategy, advisory boards, launch support, congress planning and execution).
4. Provide medical scientific input for the assigned program/brand(s) to:
a. Develop Clinical Development Plan (CDP section related to MA activities)
b. Guide and develop local MA clinical programs
c. Participate in the scientific review of local MA studies and Investigator Initiated Trials
5. Support GBMD/Portfolio GBMD in providing input into brand safety related activities for the assigned program.
6. Participation in on-boarding, training and mentoring activities offered to Novartis associates [including ECPM Course (Basel-Strasbourg and Fribourg University) tbd.]
Ideal Background
Education:

MD specialized in Respiratory Medicine with ≥ 2 years of clinical research experience as an investigator or co-investigator
Languages:
Fluent English (oral and written)
Experience/Professional
Requirement:

Advanced medical/scientific writing and communication skills.

Ability to interpret, discuss and represent efficacy and
safety data relating to the assigned area.
Role Dimensions
Impact on the
organization:
Not Applicable
Financial responsibility

None
Decision making:

Together with GBMD/portfolio GBMD responsible for MA plans and
associated activities
P&L / associates:

No direct reports
ERS Medical Fellow
Final July 6, 2015
2