Trabajos
>
Barcelona

    Strategic Operations Lead, Global Medical Information and Medical Review - Barcelona, España - Alexion Pharmaceuticals

    Alexion Pharmaceuticals
    Alexion Pharmaceuticals Barcelona, España

    hace 5 días

    Default job background
    De jornada completa
    Descripción

    This is what you will do:

    The Director, Strategic Operations Lead, Medical Information and Medical Review (GMI-MR) is responsible for providing business and operations strategy partnership for global medical information and medical review. This individual will manage all Global Medical Information & Review operations, including governance of global contact and call centers, other vendors, ensuring audit and inspection readiness and providing oversight of all Standard Operating Procedures (SOPs), Working Practice Documents (WPDs), Budgeting, and Training Materials. This person will also be responsible for identifying and implementing operational efficiencies and ensuring systems/databases support efficient workflows, and metrics inform strategic growth and resource allocation. As Strategic Operations Lead, this individual will have a pivotal role in defining the digital strategy roadmap for GMI-MR in close partnership with Global Medical Affairs.

    You will be responsible for:

  • Overseeing the Strategic Operations function of Global Medical Information and Medical Review (GMI-MR) department ensuring continual improvement and Operational Excellence of Medical Information and Medical Review process and between therapeutic areas.
  • Creating quarterly and annual metrics to broadly educate on key deliverables and turn-around times, inform strategic growth and determine appropriate resource allocation.
  • Driving departmental annual budgeting planning process, tracking and reporting monthly accruals / forecasts, and ensure spend is within 5% of Annual Operating Plan (AOP).
  • Managing a global internal team as well as vendors, ensuring audit and inspection readiness and providing oversight of all Standard Operating Procedures (SOPs), Working Practice Documents (WPDs), oversight of metrics and insight reporting, and training materials, modules and/or curriculums related to GMI-MR.
  • Providing oversight of Medical Review by contributing to process improvements, providing guidance, and collaborating with cross-functional leaders, and serving as a point of contact for process escalations
  • Oversight of Medical Material Review [MMR] Operations, vendor management, departmental project management, budget planning, customer insights and KPI reporting.
  • Provide on-site operational support for Medical Information booth at Tier 1 European Congresses
  • Oversight of all GMI-MR technology, systems, and databases (including global medical information database and call center).
  • Evaluating, establishing and maintaining the operating model and global style guide for the development and maintenance of GMI response documents.
  • Managing development and oversight for all GMI-MR training materials, including development of all applicable training modules, curriculums and maintenance of departmental training matrix.
  • Achieving and maintaining compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Alexion are carried out with the best industry practices and the highest ethical standards.
  • The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.

    • You will need to have:

  • Advanced degree or commensurate experience in health sciences, business administration, or project management with 7+ years of experience in the biopharmaceutical industry preferably in Medical Affairs, Medical Information, or Medical Communications
  • Demonstrated people management experience (3-5 years) and ability to develop staff.
  • Experienced in contracting, finance and approvals, and performance management.
  • Demonstrated strong project management skills (5 years) and proven ability to execute on small and large projects via direct reports or via a matrixed environment.
  • Experience in developing work practice documents, SOPs and effective training materials
  • Vendor management and budget oversight experience
  • Highly detail-oriented and proven ability to collaborate cross-functionally.
  • Excellent written and verbal communication skills
  • Self-motivated to drive for results, with strong organizational and planning skills.
  • Highly proficient with Microsoft Office Suite
  • Ability to travel to meetings / conferences (predominantly in Europe) as required, varied by quarter but approximately 15% of the time.
  • 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.

    • We would prefer for you to have:

  • PharmD, MD or PhD with operational experience
  • PMP certification
  • Extensive experience working with medical information or medical communication systems / databases (e.g., Veeva) Medical information / medical communication experience globally.
  • Understands drug development, health authority regulations, reporting requirements for pharmacovigilance events and product complaints, and best practices for handling medical information requests both US and internationally.
  • Experience working in medical, legal, and regulatory (MLR) review committee for the review and approval of promotional and non-promotional materials.
  • Experience leading medical information initiatives for a product launch.
  • Training or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies.
  • Demonstrated project management skills.
  • People management experience

    • Date Posted

    05-Apr-2024

    Closing Date

    30-Jul-2024

    Alexion 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.

  • Alexion Pharmaceuticals

    Associate Director, International Medical Review and Medical Information Lead

    hace 1 semana

    Alexion Pharmaceuticals Barcelona, España De jornada completa

    Position Summary · The International Medical Review Lead reports into the Sr. Director Global Medical Information and Medical Review (GMI-MR) and is responsible for leading the Medical Review function as part of the Medical, Legal, and Regulatory (MLR) review committee. This ind ...

  • Sunhero

    B2c - Field Sales Agent (Barcelona)

    hace 1 día

    Sunhero Barcelona, España

    **What about us?** · At Sunhero, we are on a mission to make Solar Energy accessible and affordable for everyone. With +20 years of experience developing international businesses, Christopher Cederskog and Stefan Braun founded Sunhero in 2021 with a clear focus: lead the energy t ...

  • TFS HealthScience

    Clinical Research Physician

    hace 3 días

    TFS HealthScience Barcelona, España

    **About this role** · TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourci ...

  • Alexion Pharmaceuticals,Inc.

    Associate Director, Global Scientific Communications

    hace 2 días

    Alexion Pharmaceuticals,Inc. Barcelona, España

    Location: Barcelona, Spain · Job reference: R-192558 · Date posted: 02/20/2024 · **Associate Director, Global Scientific Communications** · **Barcelona based, in office 3 days per week.** · **This is what you will do**: · The Associate Director, Global Scientific Communications f ...

  • Alexion Pharmaceuticals,Inc.

    Director, Global Scientific Communications

    hace 2 horas

    Alexion Pharmaceuticals,Inc. Barcelona, España

    Location: Barcelona, Spain · Job reference: R-195594 · Date posted: 03/22/2024 · The Director, Scientific Communications, Nephrology leads the successful development and implementation of global communications strategies, publications plans and medical education initiatives acros ...

  • Barrington James

    Global Clinical Development Director

    hace 1 semana

    Barrington James Barcelona, España

    We are partnered with an internationally renowned pharmaceutical company who are currently looking for a Clinical Development Director with at least 5 years of industry experience (pharma/biotech). · You will serve as a medical expert for the study team and medical monitor for Ph ...

  • AstraZeneca

    Global Development Scientist Director, Late Oncology

    hace 1 día

    AstraZeneca Barcelona, España

    **Loction: Barcelona (On-site)** · We are looking to hire a Global Development Scientist Director Late Oncology. · Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial ...

  • AstraZeneca

    Global Development Scientist Director Late Oncology

    hace 1 semana

    AstraZeneca Barcelona, España

    Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the s ...

  • AstraZeneca

    Global Development Medical Directors, Late

    hace 1 semana

    AstraZeneca Barcelona, España

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical ...

  • AstraZeneca

    Global Development Scientist

    hace 1 semana

    AstraZeneca Barcelona, España

    **Opportunity**: Global Development Scientist - The Vaccines and Immune Therapies · **Business Area**: Vaccines & Immune Therapies Late Development · **Locations**: US: Gaithersburg/Durham, Sweden: Gothenburg, Spain: Barcelona · **Salary**: Competitive, with excellent benefits · ...

  • AstraZeneca

    Global Development Scientist Director/senior

    hace 1 semana

    AstraZeneca Barcelona, España

    **_Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following th ...

  • Evidenze

    Epidemiologist Vaccines

    hace 1 día

    Evidenze Barcelona, España

    ***: · The main responsibility of the Epidemiologist is to provide support for the development and management of post-marketing (pharmacoepidemiological) vaccines studies · **OVERALL RESPONSIBILITIES**: · - Conduct literature reviews · - Write and/or review study protocols, quest ...

  • Barrington James

    Global Clinical Development Director

    hace 1 semana

    Barrington James Barcelona, España

    Barcelona · - JOB TYPE · - Permanent · - EMP TYPE · - Full-Time · - EXPERTISE · - Business Services, Clinical Development · - SALARY TYPE · - Annually · - SALARY · - Negotiable · We are partnered with an internationally renowned pharmaceutical company who are currently looking fo ...

  • Vall d'Hebron Institut de Recerca

    Project Consultant and Medical Writer-new

    hace 2 días

    Vall d'Hebron Institut de Recerca Barcelona, España

    VHIR-RRHH-FOR-003_vs01_ · TheVall d'Hebron Research Institute · (VHIR) is a public sector institution that · promotes and develops the research, · innovation and biosanitary teaching of the · Vall d'Hebron University Hospital. Through · the excellence of our research, we identify ...

  • MMS

    Principal Biostatistician

    hace 1 semana

    MMS Barcelona, España De jornada completa

    This is a remote, fulltime freelance consulting role. · **Roles and Responsibilities** · - Supporting early phase clinical trials (First in Human to PoC and clinical pharmacology) - support on-going studies with clinical data analyses and reporting out for CSR. Review and creatio ...

  • AstraZeneca

    Senior Global Development Medical Director, Late

    hace 6 días

    AstraZeneca Barcelona, España

    **Job Description**: · **Senior Global Development Medical Director** · **About AstraZeneca**: · AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of ...

  • Asphalion

    Medical Device Manager

    hace 1 día

    Asphalion Barcelona, España

    We are looking for a Regulatory Affairs Manager · - Medical Devices with experience within the medecth and/or pharmaceutical industries and team management to join us, someone who loves to take on new challenges, to work in an international environment and who wants to grow with ...

  • AstraZeneca

    Sr. Global Development Medical Director, Late

    hace 3 días

    AstraZeneca Barcelona, España

    **Senior Global Development Medical Director** · **About AstraZeneca**: · AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most seriou ...

  • Novartis

    Medical Lead

    hace 1 semana

    Novartis Barcelona, España

    391874BR · **Medical Lead - Solid Tumors**: · Spain · **About the role** · 1 therapeutic area with 1 of our top brands, that's where you will dedicate your efforts as a Medical Lead in Novartis. You will be responsible for supporting the design, implementation, and execution of M ...

  • AstraZeneca

    Global Development Medical Director, Late Oncology

    hace 2 horas

    AstraZeneca Barcelona, España

    **Global Development Medical Director** · **About AstraZeneca**: · AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious disea ...