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Responsibilities:

• Excellent employment opportunity for a Global Publications Leader in the Gaithersburg, MD area.
• The Global Publications Leader (GPL) has direct accountability for the development and execution of strategic publication plans for global clinical studies and non-clinical trial sources.
• As part of this role the GPL engages and collaborates with external experts, investigators, journals, conference organizers and external bodies to develop and manage effective external relationships to deliver strategic publication and communication activities.
• The role also interfaces with the Global Medical Affairs Leaders (MALs), US Publication Leads, marketing companies and external experts / thought leaders that form part of the global cross-functional publication teams that develop and deliver external scientific communications plans for prescribers, payers, and patients.
• The GPLs are responsible for ensuring ethical compliance with company policy and external publication guidelines of the publications plans and deliverables, and that all publications represent a transparent and fair balance communication of data, and thus enhance the Company's external scientific reputation.
• Lead the translation of scientific, clinical and evidence planning data into appropriate timely publications for prescribers, payers, and patients through disease area and product insights and effective collaboration with cross-functional teams and alliance partners where applicable
• Track existing publication plans by brand and study to ensure alignment with evidence plan.
• Lead the generation of a quarterly internal newsletter that provides updated information on study conduct and results communications as appropriate by brand
• Lead day-to-day management of assigned publication plan, delivery of outputs, financial tracking and meeting activities, working closely with all members of the delivery team.
• Develop thorough understanding of internal stakeholders in order to further the leverage of clinical and Medical Evidence Center (MEC) studies
• Lead a cross-functional global publications team and serve as key internal and external point of contact regarding publication program status ensuring proactive communication of overall status with cross-functional team, investigators, and alliance partners to ensure the needs of the regions and key market (US, Europe, Japan) countries
• Lead and facilitate project kick-off meetings and ensure each project is aligned with product strategy and messages as appropriate through liaison with the Medical Affairs Leaders (MALs) and other members of the cross-functional team.
• Lead cross-functional project team meetings
• Collaborate effectively with US Publication Leads and publication managers in other markets or regions to ensure publication activities are captured and aligned with the global publication plans while still meeting the local needs of each market
• Responsible for ensuring all publication activities meet with Company, external publication standards, and transparency requirements and that all Company internal stakeholders are adequately involved in their approval
• Lead and deliver publication advisory boards where necessary for strategic input to the brand in collaboration with MALs and medical colleagues
• Lead the development of medical, scientific vocabulary and terminology as needed in close collaboration with cross-functional colleagues
• Liaise with MALs and medical colleagues in an advisory capacity to align publications strategy and plans with the scientific exchange programs led by the MALs.
• Consult on potential speakers and specific content as required
• Liaise with Medical Evidence Directors and Scientific Leads during the planning and execution of MEC studies
• Provide publications and external communications expertise, insight and input into the cross-functional product-related teams' communications platforms and product planning phase and be the interface with medical and marketing company teams, as well as Alliance personnel for publication related updates and activities
• Provide publications expertise and insight to develop effective operating models and build effective relationships with Alliance partners as required by the business needs
• Forecast and secure resources necessary for timely and cost-effective delivery of publication plans and activities
• Lead the company RFP process in conjunction with procurement to select medical communication agencies or contract freelancers
• Manage the output, compliance and budget as per contract terms for medical communication agencies or contract freelancers responsible for key publication plan deliverables
• Manage the development, review and compliance documentation for responsible publications plan, including the publication compliance tracking tool, Datavision
• Provide publications metrics for responsible Therapeutic Area or product to the Publications Director and act upon publication metrics for the measurement of compliance and external reputation
• Drive the innovation and adoption of new publication guidelines, standards and technologies as appropriate for product-related activities
• Contribute to the development of the publications skills group, sharing best practices and lead major projects for the skills group when required
• Keep up to date on external environment, with respect to publishing Compliance with all external codes and ethical standards in medical publishing, including the Corporate Integrity Agreement
• Lead the publications risk mitigation procedure and assess all identified publications for risk mitigation
  

Experience:

• Relevant post-graduate degree
• Demonstrated experience in Medical Communications gained through working in the Pharmaceutical industry or a Medical Communications agency
• Demonstrated Project Management experience
• Broad understanding of Drug Development process
• Demonstrated performance, budget, and resource management skills in a global organization
• Excellent leadership and Project Management skills to deliver in a complex multidisciplinary environment
• Ability to establish and maintain professional relationships with external experts, investigators, journal editors and publishers and professional bodies
• Ability to effectively manage multiple stakeholders and projects to within budget
• Flexibility and adaptability to manage long-term activities in a constantly changing internal and external environment

Desirable Requirements

• Experience of working globally, cross-culturally and cross-functionally
• Strong therapeutic knowledge in AutoImmune with proven ability to adapt quickly to other therapeutic specialties