350462BR
Aug 08, 2022
China

Job Description

Job Purpose
Facilitate or drive drug LCM for responsible post-marketing product/disease area (Ribociclib /Kisqali/Breast Cancer) and ensure alignment between global strategy & local needs. Provide up-to-date medical expertise to support Novartis message delivery to key influencers and stakeholders. Ensure timely development of medical strategy as well as effective implementation. Compliance with applicable policies, procedures and other regulations.

Major Accountabilities
• Develop and implement medical strategies / plans for responsible post-marketing products independently or with support from line manager, ensure strategic alignment with global strategy and local business needs.
• Deliver high quality medical education/training materials for external and internal activities independently or with support from line manager.
• Establish strong working relationships with key stakeholders internally (brand teams, MSL, clinical operation team) and externally (eg, consultants, KOL, professional societies).
• As a core member of brand team, participate brand team meeting and provide medical insight to brand strategy for assigned post-marketing products.
• In align with global and local medical strategy and based on local marketing needs, organize phase IV trial, PMS, IIT/third party study, RWE, including:.
a. Develop and implement medical strategies / plans for post marketing studies including local PMS / Observational studies/Phase IIIb / IV stud-ies/registries/RWE and ensure alignment with brand strategy and local unmet needs.
b. Ensure GCP compliance and adherence to Novartis Standard Operating Pro-cedures (SOPs) or WIs for conduct of all trial related activities, be responsible for deliver, or supervise the process of:
- Concept sheet, synopsis, protocol and preparation of other trial initiation documents
- Trial approval at the required level (Local, Global, EC, CFDA if applicable) and review/approval of amendments
- Budget preparation, review, approval and tracking, ensure payment is made according to pre-defined payment schedule in the contract
- CSR and publications within planned timeline
- Documentation/archiving required document in TMF or IIT project binder following the related SOPs/WIs within the request time
- Trial closure following global/local related SOP/WI
- Drug forecast and preparation in case NVS will provide free drugs
c. Ensure adequate medical support and contribution to the ongoing scientific review during clinical trial implementation by attending regular meetings including project planning/review meeting, investigators meeting, internal virtual meetings, etc.
d. Make decisions regarding eligibility, enrolment and data consistency, and in-put to AE/SAE management.
e. Define IIT Strategies and responsible for oversee and manage the whole process of IIT execution including contract, payment and publication in alignment with GCP, Local regulations, NVS SOP
f. Oversee and manage animal and in vitro studies (investigator initiated pre-clinical studies, optional item in the JD)
g. Supervise or responsible for CRO Management (Database, Contract and CSR) in IIT.
• Lead local Advisory Board meetings for LCM of responsible post-marketing products/disease areas.
• Review/approve promotional materials and ensures the materials fully align with NP4 from scientific point of View.
• Develop publication strategies / plans and key scientific messages to ensure strategic alignment with regards to scientific communication and increase share of voice for responsible post-marketing products.
• As China medical representative to exposure at global related platform
• Actively participate GDD CPT meeting on behalf of responsible compoud from medical
• Offer medical support to other departments, e.g. KAM, marketing access

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Education: Master degree or above in clinical medicine,Oncology preferred.

Languages: Fluent English in listening, speaking, reading and writing.

Experience:
• Nice to have a minimum of 3 years Oncology experience , understand current clinical practice.
• Must have Medical advisor experience within a disease area, especially oncology preferred.
• Proven ability to work both independently or in a cross-functional team setting.
• Proven ability to design, interpret, discuss and represent clinical trial data and establish effective working relationship with investigators and KOLs
• Ability to write / edit scientific articles, posters and abstracts. - Ability to align key messages with clinical studies and publications.
• Excellent interpersonal skills. Ability to work with internal and external stakeholders.
ONCOLOGY
ONCOLOGY BU
China
Shanghai
Research & Development
Full Time
Regular
No
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350462BR

(Senior) Medical Advisor, Breast Cancer

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