Associate Director Medical Writer

#LI-Hybrid

This position is based in Barcelona, Spain. Please apply only if this location is accessible to you, as relocation support is not available.

Key responsibilities but not limited to:

• Lead the authoring, review, and independent management of Safety Concerns and other critical content in Aggregate Reports and RMPs.
• Review and ensures HA comments are addressed in all relevant department’s deliverables for a product / class across the TAs in collaboration with Medical function, QPPV office and other global stakeholders.
• Lead preparation of Aggregate Reports for newly launched and acquired products as well as for first risk management plans for initial submissions and new indications.
• Develop and implements strategies for data analysis and presentation across global Aggregate Reports, RMPs, and other departmental deliverables; actively contributes to planning and reviewing statistical analysis plans, ensuring clarity, accuracy, in all submissions
• Contribute to complex cross functional global projects focusing on quality improvement and contribute to projects on process improvement initiatives including IT projects/systems (including AI) which are of high priority/ criticality to the business.
• Provide expert opinion in the development of safety document templates and Standard Operating Procedures pertaining the department’s deliverables to comply with emerging worldwide regulations.
• Provide impact assessment on the department’s deliverables for any new process proposals, process improvement proposals etc.
• Identifies knowledge gap, develops training materials and conducts workshops.
• Mentors associates to enhance their skills and contributions.
• Leads capability building initiatives for medical safety writing and future projects.
• Collaborates with process owner on process simplification and improvement initiatives Business interface with key stakeholders within and outside Novartis including HAs.
• Ensures team awareness and assess impact of updates to global PV regulatory requirements for department’s deliverables.
• Works jointly with Compliance & Quality and Process compliance & Risk Mitigation functions to support trend analyses, knowledge generation and mitigation of any identified risks.
• Deputize Team Lead / Group Head and assists with the recruitment of new staff.
• Work predominately in the field of medical writing and can contribute to RMP Management after appropriate training.

Essential requirements:

• Education and/or professional experience: Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree
• Fluent English (oral and written)
• At least 7 years’ experience in drug safety / development or closely related areas of responsibility, with a minimum of 5 years’ experience in safety writing.

Desirable requirements:

• Excellent understanding of the disease area
• Sound expertise in data analysis and presentation
• Strong project management and communication skills.
• Ability to lead global and cross-functional work groups.
• Excellent understanding of drug development process, GCP and medical terminology
• Ability to mentor and guide