Medical Affairs Publications Manager

2 mesi fa

Rome, Italia EUSA Pharma A tempo pieno
Job PurposeOversee the development and implementation across the two BUs of the publication plans for global and local clinical studies and non-clinical trial sources, including HEOR, Epidemiology, RWE, Payer, non-Interventional and database studies, ensuring compliance with regulatory guidelines and industry standards. Manage the effective preparation, communication and dissemination of medical/scientific information (e.g. publications, abstracts, posters, manuscripts) to external stakeholders. Key Responsibilities•

Strategic Planning: In collaboration with Corporate, Global and affiliates teams, support the development of the strategic publication plans, including scientific publications, abstracts, posters, manuscripts, to effectively communicate scientific data, research findings, and product/scientific information to external audiences. Liaise with medical evidence/OR and medical/scientific leads during the planning and execution of Real World Evidence studies. •

Publication Management: Manage the development and approval process for documents included in the publication plans within timelines, in collaboration with the medical teams, including support in documentation generation, initiation of review process, discussions on proposed revisions, document finalization and submission of scientific publications. •

Cross-functional Collaboration: Collaborate with medical affairs, clinical development, marketing and other departments as appropriate to ensure alignment of communication efforts with organizational goals and compliance requirements. Support teams in translation of scientific, clinical and real world evidence into appropriate timely publications for healthcare professionals, payers, and patients. Collaborate effectively with medical and/or publication leads in countries or regions to ensure publication activities are captured and globally aligned while still meeting local needs. •

Regulatory Compliance: Keep up to date on external environment, with respect to publishing Compliance with all external codes and ethical standards in medical publishing, to ensure that publications materials adhere to relevant internal SOP as well as national/international regulations and guidelines. •

External Engagement: Provide publications expertise and insight to develop effective operating models and build effective relationships with external partners as required by the business needs. Support the teams in procurement process which may include attending pitches and finding best external agency. Maintain relationships with key opinion leaders, investigators, medical writers, and external vendors to support the publication process and enhance scientific exchange. •

Training and Development: Provide guidance and support to corporate, global and affiliates teams on scientific communication principles, publication planning, and writing techniques to enhance capabilities and ensure high-quality deliverables. •

Risk Management: Identify potential risks and challenges related to medical publications activities and develop mitigation strategies to address issues proactively. •

Performance Metrics: Define and track key performance indicators (KPIs) to evaluate the effectiveness of communication strategies, publication outputs, and stakeholder engagement initiatives. Provide updates of scientific publication activities on a regular basis. •

Budget Management: Manage the budget for medical communication activities, including publication planning, agency fees, and conference attendance, ensuring optimal resource allocation and cost-effectivenessRequired EducationBachelor degree in the life sciences or communications fieldRequired Skills and ExperienceThis position requires a strong background in medical writing, project management skills, and the ability to collaborate cross-functionally with various teams. •

Minimum of 5-7 years of experience in medical communication, publication management, or related roles within the pharmaceutical or biotechnology industry. •

Strong understanding of medical writing principles, publication planning processes, and scientific communication standards. •

Familiarity with industry guidelines and standards (e.g., ICMJE) governing scientific publications and medical communication. •

Excellent project management skills with the ability to manage multiple projects simultaneously and meet tight deadlines. •

Broad understanding of drug development process, proficiency in interpreting and summarizing scientific data and clinical trial results. •

Excellent written and verbal communication skills, with attention to detail and accuracy. •

Ability to work effectively in a global, cross-functional, cross-cultural team environment and to influence stakeholders at various levels of the organization. •

Ability to establish and maintain professional relationships with external experts, opinion leaders, investigators, journal editors and publishers and professional bodies. Desirable for the role: Previous experience in one or more therapeutic areas in which Recordati operates (eg endocrinology, oncology, immunology, metabolic diseases, CV, urology)Required LanguagesExcellent verbal and written English.

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