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Director, Global Publications

Company: Santen, Inc.
Location: Emeryville
Posted on: January 15, 2021

Job Description:

COMPANY DESCRIPTION: At Santen, we---re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field---through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States. We are in search of top talent to help us meet our aggressive and important goals. ABOUT THE POSITION: The Director, Global Publications is an emerging leadership position within Medical Communications with substantial strategic input across Global Medical Affairs (GMA) for assigned product(s) or therapeutic area(s) within Santen. The Director will focus on shaping and defining scientific message platforms and related publication plans for all global products. This includes synthesizing stakeholder input, ensuring alignment cross-functionally, conducting gap analyses, and defining and facilitating decision-making on publication strategy for all therapeutic areas for all markets. The Director will also lead content creation activities including oversight of agencies, authors, internal Santen staff, and ensure compliance with all Santen and industry standard publication processes. This position will oversee the advancement and implementation of an end-to-end globalization publication process including publication management systems and tools, and training and managing of end users. This position will be responsible for managing global publication budget, and departmental activities, as needed. The position reports to the Senior Director of Medical Communications, GMA. RESPONSIBILITIES: Publication Strategy and Planning: Lead globalization of publication planning and publications to support to the expanding scope of GMA activities Lead regular publication planning meetings to ensure global organizational alignment Analyze current messaging database and published literature to identify gaps in scientific knowledge base; ensure identified gaps are represented in strategic publication plan Collaborate with Santen stakeholders to facilitate the development of publication concepts that address identified gaps and address unmet needs Oversee publication planning and development of all publications including key scientific research based on clinical development milestones, clinical study outcomes, health economic and outcomes research, value and access issues, and stakeholder commentaries and articles Publication Content Creation: Ensure all publication outputs meet the highest standards of medical/scientific integrity Ensure appropriate adherence to authorship and publication guidelines as stipulated by Santen operating procedures, ICMJE, GPP1- GPP3 Work closely with medical directors, biostatistics, clinical science, research, and other Santen global colleagues to ensure timely collation, interpretation, and reporting of data to support publication plans; perform or facilitate data reviews as needed Manage publication managers, agency and/or contract medical writers and/or statistical programmers for content creation Publication Process, Systems, and Reporting: Oversee the global, strategic consideration and appropriate internal review of new abstract/publication concepts; ensure compliance with all documentation steps for Santen and respective congress guidelines Oversee the maintenance of all publication records in Publication Management system; perform periodic audits with publication managers to determine completeness of records and level of compliance; use the results to identify potential areas for process improvement Ensure all published works are recorded, disseminated internally, and used to derive new scientific messages Represent all publications in development and key forums for review and approval Work with operations team to optimize globalization of all publication management systems, including keeping user, drug, research, and study information up to date; maintaining workflow and email templates; managing built-in filtering and reporting capabilities; and monitoring integration with the internal publication review and approval systems Provide periodically updates to upper management Worked with leading publication management systems such as Datavision, Pubstrat etc. Ability to analyze and justify journal selections for publications Scientific Messaging Development: Work with cross functional colleagues to develop scientific narrative story all Santen products to have successful launch Examine relevant literature and competitive intelligence on an ongoing basis a provide and updates to medical affairs team Review cross-departmental materials to ensure alignment with scientific messaging database Collaborate with cross-functional stakeholders to identify messaging needs/gaps; ensure messaging gaps are widely known and documented in global strategic publication plans Functional Leadership: Serve as the global publication lead to the entire GMA team Manage team of publication managers and supporting coordinators/assistants Respond to internal and external questions about any publications for any product area Participate in cross-functional team meetings to share publication planning status and issues and maintain awareness of all publication plans Lead and/or contribute to functional improvement initiatives for the emerging MSL teams Oversee the development of publication planning Provide support for management of the annual GMA publications and congresses budget Ability to work in a matrixed environment and collaborate well with peers and other cross-functional colleagues REQUIREMENTS : BA/BS in life or health sciences with publications experience; Bachelor---s Degree, advanced degrees in health sciences or related fields are highly preferred (MD, PhD, PharmD, MS) 7-10 years of relevant experience in medical communications, publication planning and/or medical writing 5 or more years of experience managing a team of direct reports Experience managing vendors specializing in scientific platforms and publications management Ophthalmology therapeutic area experience is preferred Excellent communication, presentation, and negotiation skills Strong interpersonal and partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams Demonstrated experience of successfully influencing cross-functionally, cross-culturally, and cross-brands Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources Awareness and understanding of regulatory guidelines (FDA, PDMA, PhRMA, etc.) and how they apply to scientific communications and medical education Ability to travel up to 20% domestic and internationally, potentially to attend scientific congresses and relevant meetings

Keywords: Santen, Inc., San Francisco , Director, Global Publications, Executive , Emeryville, California

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