Senior Manager Global Scientific Communications

Competitive
Permanent
Cork
21 Mar 2020
BBBH756673

Senior Manager - Global Scientific Communications

Cork

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.

Key Responsibilities:

  • 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.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF LA CRÈME SERVICES.

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