Medical Affairs Manager

MEDICAL AFFAIRS MANAGER WILMINGTON, DE Position is Remote. Required Skills:

• Bachelor's degree in the health sciences or communications field.
• 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.

• Relevant post-graduate degree.
• Experience of working globally, cross-culturally, and cross-functionally.
• Strong therapeutic knowledge in respiratory, diabetes, cardiovascular or renal disease areas with proven ability to adapt quickly to other therapeutic specialties.

• The Publications Leader has direct accountability for the development and execution of strategic publication plans for global clinical studies (Phase III onward) and non-clinical trial sources including HEOR, Epidemiology, RWE, Payer, Non-Interventional and database studies.
• As part of this role the Publications Leader engages and collaborates with internal colleagues and external experts, investigators, journals, conference organizers and external bodies to deliver strategic publication and communication activities.
• The role also collaborates effectively with regional and country affiliates to develop and maintain integrated external scientific communications plans for regional and local healthcare professionals, payers, and patients.
• The Publications Leaders are further responsible for ensuring ethical compliance with the Client's policy and external publication guidelines of the publications plans and deliverables, and they ensure that all publications represent transparent and fairly balanced communications that enhance the Company's external scientific reputation.
• Lead the translation of scientific, clinical, and real-world evidence into appropriate timely publications for healthcare professionals, payers, and patients.
• Lead day-to-day management of assigned publication plans, including financial forecasting and tracking, working closely with all members of key cross-functional product teams to optimize communication of R&D and Medical Evidence study results.
• Lead a cross-functional 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 countries.
• Lead and facilitate project kick-off meetings and ensure each project is aligned with product strategy and communications objectives as appropriate through liaison with the Medical Affairs Leaders (MALs) and other members of the cross-functional team.
• Lead publication steering committees where necessary in collaboration with study investigators and other internal colleagues.
• Collaborate effectively with Publication Leads in countries or regions to ensure publication activities are captured and globally aligned while still meeting local needs.
• 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 Real-World Evidence 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 regional and country medical teams 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.
• Lead the development of medical and scientific lexicons as needed in close collaboration with cross-functional colleagues.
• Forecast and identify resources (e.g., statistics, medical writing) necessary for timely and cost-effective delivery of publication plans and activities.
• Provide publications metrics for responsible Therapeutic Area or product to the Head of Publications and act upon publication metrics for the measurement of compliance and external reputation.
• Keep up to date on external environment, with respect to publishing Compliance with all external codes and ethical standards in medical publishing.
• Ensure all publication activities meet with the Client's and external publication standards as well as transparency requirements and that all the Client's internal stakeholders are adequately involved in reviews and approvals.
• Drive the adoption of new publication guidelines, standards, and technologies as appropriate for product-related activities.