Senior Manager - Global Scientific Communications
I am currently working with a leading global pharmaceutical company based in Cork who are seeking an experienced Senior Manager for a new Global Scientific Communications team.
This is an excellent opportunity to take lead of a new team within an innovative and cutting-edge organisation who are not only market leaders but also a highly sought-after employer due to their excellent culture.
The ideal candidate will have extensive stakeholder management and scientific communications experience across both publications and regulatory.
- Accountable for management/delivery of overall book of work across department
- Develop and execute sourcing and submission plans in partnership with appropriate managers to ensure seamless delivery of asset plan and priorities.
- Collaborate with internal 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 global colleague
- 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 team leadership to plan various regulatory strategies/scenarios and their impact in order to make effective decisions, mitigation's and optimize regulatory submissions
- Ensure that issues are resolved at the lowest level while identifying and resolving those that require escalation.
- 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.
- Recruit develop and retain a strategic and operationally capable workforce skilled and knowledgeable in scientific communications.
- Provide input on employee development, talent assessment, and succession planning activities.
- Provides guidance, training, and supervision to personnel.
- Monitor the workload of the full team of writers, tracking timelines and quality, Communicate priorities to direct reports.
- Provide technical support and guidance to direct reports as needed.
- Evaluate performance by reviewing documents and attending writing team meetings and recommend developmental actions for all assigned staff.
- Provides regulatory document/submission expertise to other functions as expert on regulatory requirements, document strategy, planning and execution, and industry standards and guidelines.
- In partnership with others, designs, creates and implement, training on submission/regulatory practices for audiences both internal and external.
- Analyse and interpret new and updated industry guidelines for applicability
- In partnership with others, develop, implement, and update company policies, procedures, training, and tools that are compliant with industry guidelines.
Qualification / Experience Required
- Advanced degree (MBBS, MD, PharmD, PhD, MPH).
- Extensive 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.
- 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.
- Experience leading submission or launch activities.
This is an opportunity to play an integral role in the establishing of this new team and join an innovative and cutting-edge organisation who places people at the centre of all they do.
Please contact us for a confidential discussion on this exciting opportunity.
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