Senior Manager Scientific Communications Regulatory
Our client, a global pharmaceutical organisation are currently recruiting for a Senior Manager Scientific Communications (Regulatory) to join and manage a newly created Global Scientific Communications team. As Senior Manager you will be responsible for the delivery of regulatory documents, oversee the compliance, quality, effectiveness, and implement strategic plans to optimize the team's performance. This position leads across therapy areas, compounds and phases of development. As the subject matter expert on site, this role is responsible for establishing and maintaining effective communication and partnerships with the regulatory advisorand to provide technical coaching to the writing team on the development of highly refined, high-value, submission strategy and tactical plans that facilitate technical success for molecules in the context of regulatory submission and approval.
• 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
PLEASE APPLY DIRECTLY BY CLICKING HERE
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