AstraZeneca

Manager

• Accompany team representatives on customer visits in person and/or virtually
• Ensure the creation of structured individual development plans for the entire team
• Drive the development and training of direct reports in core competencies
• Ensure quality in selection, performance management, and talent processes
• Manage the medical panel and institutions for your team
• Manage key performance indicators (KPIs)
• Apply strategic thinking aimed at delivering results
• Manage resources allocated to your region
• Consult and use Market Intelligence data
• Interact with other areas and departments
• Actively contribute to business meetings
• Challenge the status quo in pursuit of best practices
• Always act in compliance with AstraZeneca policies

District Manager — CVRM

• Responsible for managing clinical trials supply in China.
• Providing strong support to China study team, including defining clinical supplies plan of re-packaging and label design.
• Ensure study drug and clinical devices could be delivered within agreed timeline and with good quality.
• Managing clinical supply related budget.
• Monitoring and handling issues raised by study team.
• Responsible for management of Customs Affaires related activities.
• Communicate with the Customshouse and facilitate importation and exportation.
• Drive cross function discussion and collaboration to solve the Customs related issues.
• Act as Subject Matter Expert (SME) on customs policies and processes.
• Responsible for providing instructions and trainings to AZ internal team, when necessary.
• Responsible for maintaining good level of compliance with GMP, GCP, AZ SOP and related laws and regulations.
• Responsible for clinical supply related SOPs development and updating, as well as robust working tools.
• Establish performance measurement metrics for holistic clinical supply performance evaluation.
• Identify potential improvement areas and drive necessary optimization accordingly.
• Support study team solve clinical trial supply related issues or take the lead role to solve major issue where efforts from multiple parties are required.
• Responsible for across studies issue resolution, including issues related to Global Clinical Supply, clinical site and service providers.
• Responsible for clinical supply related external service provider management.

Clinical Operation Supply Manager

Compliance

• Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types
• Lead innovative regulatory strategy development and implementation, including risk identification and contingency planning that safeguard brands while enabling bold, compliant storytelling
• Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy to ensure claims and evidence align with regulatory expectations
• Provide input to global teams on how proposed TPP/TPC/TPL documents, labeling, studies, and corporate initiatives may affect US promotion; translate insights into clear guidance for US stakeholders
• Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review, address enforcement actions, and adjudicate incoming/outgoing competitor product complaints to protect brand integrity
• Evaluate brand regulatory training needs and develop and deliver training in partnership with internal/external Learning teams or the PRA Skill Center, building regulatory acumen across the business
• Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids that increase clarity, speed, and quality in review and approval
• Monitor regulatory agency activities, guidance documents, and emerging trends; distill and share implications with PRA and cross-functional partners to inform proactive planning
• Shape PRA vision, practices, and operational plans; contribute to team objectives and priorities with a focus on measurable outcomes and continuous improvement
• Act as a role model for performance and ways of working; manage, develop, and mentor less experienced staff to elevate team capability
• Represent the company as a subject matter expert internally and externally, reinforcing credibility and thought leadership in promotional regulatory affairs

Director, Promotional Regulatory Affairs

• Provide global strategic regulatory expertise and oversight
• Coach and mentor regional and global regulatory leads
• Partner with Regulatory Affairs Directors aligning innovative regulatory strategies
• Lead resource planning and recruitment of staff
• Provide critical review and input on regulatory strategies
• Represent Global Regulatory Affairs in senior level interactions
• Collaborate with regional policy and intelligence groups
• Define and drive disease area global regulatory policies and priorities
• Ensure submission excellence framework is timely and consistently applied

Executive Director, Regulatory Science & Strategy – Oncology

Therapist

• Ensure successful conduct and integrity of all in-scope clinical studies.
• Co-owners of clinical study delivery with Stats and Clinical Operations.
• Development documents content owner.
• Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety.
• Forming and running advisory board for portfolio projects.
• Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design.
• Liaise with safety physician for program-level assessment of safety information and evaluation of safety signals.
• Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables.
• Protocol development preparation for review by the Clinical Challenge and Protocol Review Committee.
• Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction.
• Be a TA clinical science expert and supporting China regulatory filing and registration.
• Lead discussions with regulatory officials on clinical science subjects of a given project.
• Provide consultation to clinical operation colleagues on protocol design questions.

Physician II, Cell Therapy

Sales

• Develop and demonstrate strong knowledge of clinical disease states and treatment guidelines.
• Effectively communicate product information to healthcare professionals to influence prescribing behavior.
• Execute call plans and Brand Strategy by translating data to actionable insights.
• Build and maintain working relationships with healthcare professionals.
• Drive portfolio demand performance through meaningful customer interactions leveraging multiple channels, such as digital platforms and face-to-face engagements to reach the customers.
• Demonstrate openness to new ideas and seek innovative approaches to sales and customer engagement.

Senior Pharmaceutical Sales Specialist, CVRM Specialty

Vice President

• Provide strategic leadership and direction for the Discovery Chemistry & DMPK function
• Partner with the senior leadership team to shape and execute the OTD strategy
• Lead the discovery, optimization, and preclinical characterization of modalities supporting the OTD portfolio
• Evolve scientific, technical, and organizational capabilities
• Work closely with OTD functional leaders and critical partner functions
• Lead, coach, and develop the senior leadership team within Discovery Chemistry and DMPK
• Provide effective operational leadership
• Drive portfolio prioritization decisions informed by scientific opportunity
• Contribute to the broader strategic direction of OTD by establishing and advancing novel synthetic modalities
• Build and maintain productive collaborations with leading academic institutions and external partners
• Maintain and elevate the scientific standing of the Discovery Chemistry and DMPK organization.

VP & Global Head – Discovery Chemistry, DMPK, Oncology Targeted Delivery

• The Patient Education Manager (PEM) is a key field-based role responsible for engaging the patient community, conducting patient education programs, partnering with advocacy groups, and supporting infusion sites of care as the subject matter expert for REMS requirements as well as product and disease education.
• The PEM will provide patients and caregivers disease state and product education, an overview on Alexion’s OneSource Programs throughout the patient journey.
• The PEM will interact with patients/caregivers, nurses, pharmacists, ancillary staff, physicians, and advocacy/support groups to prevent and address non-clinical barriers to patient education and onboarding.
• They will serve as the primary source for all regional patient community engagement activities.
• This role will support stakeholder needs for ongoing REMS topics, continuing education, audit support, and new certifications.
• They will work closely with all Alexion field roles as well as with the Commercial REMS Team to develop regional and national engagement strategies and tactics supporting ongoing REMS compliance and customer engagement.

Patient Education Manager, Hematology, Nephrology

Operations

• You drive strategic initiatives across the entire cell therapy lifecycle
• You act as the central interface and a leadership figure within cross-functional teams
• You build sustainable partnerships with treatment centers and medical stakeholders
• You apply your expertise to influence decision-making processes
• You establish and optimize operational workflows in treatment centers
• You serve as a technical expert and primary point of contact for cell therapy workflows
• You provide operational and clinical support for studies as well as commercial applications
• You ensure compliance with regulatory requirements
• You are responsible for developing and implementing training concepts for medical personnel

Associate Director – Territory Operations Manager, Deutschland

Consultant

• Criar e manter planos de atividades ou ações específicas da conta
• Identificar oportunidades de crescimento no território
• Promover e participar de eventos relacionados aos produtos
• Gerenciar recursos e a carga cognitiva
• Rastrear atividades e enviar relatórios sobre o negócio

Consultor Técnico, Doenças Raras – Neurologia

• Preparation of high-quality EU-CTR submissions for clinical trials during the start-up phase
• Submissions to ethics committees and regulatory authorities during the start-up phase (where applicable)
• Timely collection of required, high-quality documents from study sites and upload to the eTMF
• Creation, adaptation, and translation of submission-relevant documents
• Coordination of and support with handling RFIs
• Maintenance and updating of the CTMS with study site data during the start-up phase
• Proactive acceptance of task packages in the Submission Expert Group
• Contribution to process improvements, knowledge transfer, and best-practice sharing

Study Start-up Manager, Cell Therapy

• Develop and demonstrate knowledge of clinical disease states and treatment guidelines.
• Effectively communicate product information to healthcare professionals.
• Execute call plans and Brand Strategy by translating data to actionable insights.
• Adapt to and demonstrate a thorough understanding of AZ Selling Model.
• Analyze data and trends to build insightful and actionable business plans for your assigned sales territory.
• Build relationships and credibility with Primary Care healthcare professionals to effectively position products by establishing unmet needs, clinical differentiation, and fair balance of our Brands.
• Leverage multiple channels including digital platforms and face-to-face engagements to drive meaningful customer interactions.
• Open to receiving guidance and seek insights for growth and development.

Senior Pharmaceutical Sales Specialist, Primary Care

• Lead and support strategic initiatives across clinical and commercial cell therapy from development to post-market
• Establish service lines with external partners (PIs, Physicians, Nursing, Apheresis, Cell Therapy Lab, other HCPs/leadership)
• Act as primary operations readiness liaison; collaborate with Supply Chain to align logistics and site needs
• Provide exemplary customer service while building business relations with clinical/operational leaders
• Maintain strong collaboration with Program Management, SMM, Supply Chain, Manufacturing, Quality, Medical, Commercial, Cell Therapy Hub

Associate Director, Territory Operations Manager, Cell Therapy Patient Operations, Nordics

• Identify and professionally support relevant external stakeholders, key opinion leaders and medical-scientific centers
• Build and maintain robust, trust-based relationships with external stakeholders through personal scientific exchange on an equal footing
• Actively collaborate with scientific societies and relevant external partners in the hematology field
• Analyze and identify relevant network structures and actively gather medical-scientific insights and developments
• Design, organize and implement regional and supra-regional scientific continuing education events
• Participate in international, national and regional congresses, symposia and scientific meetings
• Support and accompany internal and external clinical study projects
• Create, prepare and further develop scientific presentation materials
• Support internal training programs, field force trainings and workshops
• Work closely in cross-functional collaboration with internal stakeholders, in particular Training, Marketing, Market Access and Medical Affairs
• Provide professional project management and actively contribute in cross-functional teams
• Ensure careful documentation, confident use of IT systems and openness to new technological applications including the use of AI-supported solutions

Medical Science Liaison Manager, Hematology – Cell Therapy, Multiple Myeloma

Full-stack Engineer

• Be the company-wide technical lead for assigned (bio)pharmaceutical product(s) of the portfolio encompassing a variety of modalities, primarily drug substance, raw materials through drug product packaging and associated testing of manufactured products
• Maintain knowledge and history of the product(s) process throughout the entire commercial lifecycle, inclusive of development history
• Perform process management in the following areas (but not limited to): Owner of product improvement road map, Owner of specification review committees, Owner of product technical risk summary (based on product risk register) in conjunction with product quality risk register
• Review CPV plans and outputs reports for recommendations
• Serve as an empowered Alexion Technical Operations representative working collaboratively and cross-functionally with Strategic Product Leads and Product Team members contributing to product vision, technical strategy, technical business cases, plans, and delivery
• Proactively manage risk and drive product related decisions to ensure the Product team is successful in achieving improvement goals
• Identify and lead through to approval, opportunities for process/operational improvements for replication and implementation across the manufacturing network