Major accountabilities:

• Prepares literature review, abstracts, posters, and slide sets working from various data sources including clinical study reports, patient profiles etc.
• Performs quality control (QC) checking / proof reading of above documents to meet customer expectation.
• Manages assigned individual projects.
• Obtains feedback from contributors and project teams.
• Complies with and support group’s project management tool, standards, policies and initiatives.
• Follows Novartis specifications for documentation, templates etc.
• Maintains records for all assigned projects including archiving.
• Maintains audit, SOP and training compliance.
• Performs additional tasks as assigned.

Key performance indicators:

• Preparation of the above referenced documents meeting set quality standards and on time for submission to Health Authorities/ Clinical teams / Journals as appropriate. (i.e. complying with standards e.g. CONSORT regarding publication of trial results, complying with journal formatting requirements etc).
• Publications are acceptable to internal and external authors (no issues with authorship).
• Completion of an adequate number of medical and scientific documents (taking into account complexity) per year.
• Adhere to Novartis values and behaviours.

Minimum Requirements:
Education and Work Experience:

• Minimum: Life-science degree or equivalentB.Sc./equivalent with 4 years Clinical Research (CR) experience, M.Sc./M.Pharm + 2 years of CR experienceDesired: Doctoral degree, Qualification in Medical Sciences (MBBS/MD/equivalent). PhD + 1 year of CR experience, MBBS/equivalent + 1 year of CR experience

Skills:

Functional competencies (Fundamental

• Results Driven; Customer/Quality Focus; Leadership; Innovative and creative; Action oriented; Show initiative; Empowerment / Accountability; Commitment / Self discipline; Mutual respect / Trust / Loyalty / Candor; Open Communication / Collaboration/Compassion; Drug Development knowledge; Science and Technology; Commercial Proficiency; Operational Excellence; Clinical communication & Info. Mgmt.

Leadership Competencies (Fundamental)

• Sets clear direction and aligns team and others around common objectives
• Energizes the team
• Displays passion for the 3 Cs (Consumers, Customers, Competition)
• Exercises good judgment and drives change for competitive advantage
• Drives for superior results and has passion to win
• Displays analytical and conceptual thinking

Functional Experience

• Scientific/ clinical knowledge of safety aspects, TA, disease, brand (Solid, Critical)
• Writing medical documents and publications (eg., abstracts, literature review, slide sets, posters, manuscripts, meeting reports) (Exposure, Critical)
• Clinical Research/ Drug Development (Exposure, Critical)
• Drug Safety (Exposure, Critical)
• Quality management (Exposure, Critical)
• IT/ web applications, office productivity tools and document formatting skills (Exposure, Critical)

Leadership Experience

• Project Management (Exposure, Critical)
• Third Party (Customer/Vendor/Buyer) Relationship Management Exposure (Desired)
• Driving operational excellence Exposure (Critical)

Languages :

• Excellent written and oral English skills