Associate Director, Medical Writing Operations
1 month ago
This is what you will do:
This position is responsible for managing operational aspects of the Medical Writing and Clinical Trial Transparency (MW CTT) department’s timely delivery of high-quality, regulatory-compliant documents supporting clinical development across the Alexion RDU clinical portfolio. The scope of this position includes management of and facilitation of cross-functional operational processes across MW, including management of MW vendors, implementation and maintenance of technology, and updates and maintenance of standard operating procedures supporting clinical document development and contributing industry experience to support innovation projects across MW.
You will be responsible for:
Providing oversight and tracking of all medical writing (MW) deliverables, including confirmation of up-to-date document attributes and timing, budgets, and resourcing. Working in close collaboration with the MW Team to drive best practices and support for operational excellence, innovation, capabilities, efficiency, resourcing and operational practices. Developing strategies for and managing execution of external support for the internal team with Contract Research Organizations (CROs) or other external resources, including oversight of performance management for vendors who provide medical writing services (eg, writing, QC, formatting, pre-submission publishing). Supporting vendor project resource forecasting and tracking, budget forecasting and accrual, contract negotiation in collaboration with Global Strategic Sourcing, and project metrics to ensure vendor projects perform with maximum efficiency within established timelines, budgets, and quality standards. Collaborating with MW Team members to ensure operational support for clinical project teams, including document and process quality checks, and technical/operational tools supporting MW deliverables. Maintaining up-to-date knowledge of the latest technological document development/management tools, leveraging associated advancements to support MW process improvement, and troubleshooting/escalating technology-related issues within MW. Maintaining MW standard operating procedures. Implementing and supporting innovative, sustainable, and state-of-the-art medical writing standards, tools, and systems.Qualifications
At least 5 years medical writing management and operational experience or other relevant pharmaceutical industry experience, combined with scientific, technical, and regulatory knowledge, to support MW function. Demonstrated ability to manage excellent internal and external relationships, including alliance partners and vendors; experience managing CRO relationships. Thorough knowledge of global regulatory requirements and ICH/GCP guidelines. Proven experience in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projects. Excellent communication, planning and organizational skills. Experience with MW deliverables, process, and technologies supporting global clinical studies and regulatory submissions. Excellent project management, planning, and budgeting skills. Extensive technical skills including proficiency in MS Project, MS Word, Adobe Acrobat, and electronic repositories. Team player and leader who thrives in a team-based environment. Well-developed sense of ethics, responsibility, and respect for others. Agile learner with ability to work both collaboratively and independently, seeking advice as required. High level of flexibility and ability to innovate and adapt to changing conditions. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Education:
BS or equivalent degree; advanced degree preferred.Date Posted
23-May-2024Closing Date
27-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
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