Scientific Communications Senior Manager
Our client, a global pharmaceutical organisation are currently recruiting for a Scientific Communications Senior Manager to join and manage a newly created Global Scientific Communications team.
• Accountable for management/delivery of overall book of work across the regulatory book of work assigned to the site
• Develop and execute sourcing and submission plans in partnership with regulatory leads and managers to ensure seamless delivery of asset plan and priorities
• Collaborate with function, capability, and site leadership to ensure alignment of business planning and operations
• Accountable for prioritization of work to meet portfolio needs assigned to the site in partnership with the global colleagues
• Coordinate across and develop synergies with therapeutic areas, phases of development, and geographies
• Lead and direct internal and external team members in achieving team goals
• Provide expertise in scientific writing and communication keeping up to date with country/regional regulatory requirements
• Consult with Regulatory Leads and team leadership to plan various regulatory strategies/scenarios and their impact in order to make effective decisions, mitigations and optimize regulatory submissions
• Partner in the selection process and may manage relationship for preferred vendors
• Regularly report results of team activities/metrics to leadership and stakeholders
• Ensure audit and inspection readiness, quality, and compliance to ensure deliverables are accurate, transparent, of high quality, and in compliance with internal/external guidance/regulation.
• Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in scientific communications.
• Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio
• Lead development of new and emerging capabilities to support the effectiveness of the group.
• Provide regulatory document/submission expertise to other functions as expert on regulatory requirements, document strategy, planning and execution, and industry standards and guidelines
• Master’s degree in a scientific, health, communications, technology, health outcomes, or public health related field
• 4 years’ experience in regulatory medical writing within the pharmaceutical business
• Experience leading/ writing regulatory submission for medical assets or delivering key submission activities (Efficacy, Safety)
• Experience leading others, including relationship and team building, setting expectations, holding others accountable, and technical coaching
• Strong scientific communication skills, including extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically
• Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills
• Successful completion of writing exercise.
• Advanced degree (MBBS, MD, PharmD, PhD, MPH)
• Educational/work background in a health care, medical affairs, clinical development, health outcomes, public health, scientific or medical communications field
• Expertise in industry standards and best practices, compliance issues, and regulatory requirements
• Strong leadership, problem-solving skills, negotiation/influence/motivation, project management and critical thinking skills with ability to use effectively in a team, cross-functional setting and/or global environment
• Clinical pharmacology, therapeutic area or other medical/scientific-specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, endocrine, health outcomes, public health)
• Experience managing business plans, budgeting and capacity resourcing
• Knowledge of scientific, statistical, and research principles and guidelines
• Experience in the global environment and an appreciation for global diversity
• Knowledge of software/tools used in scientific writing
• Experience leading submission or launch activities
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252