Scientific Expert

1 semana atrás


Lisboa, Lisboa, Portugal Organon Tempo inteiro

Job Title: Scientific Expert - Regulatory Affairs Leader

About Organon:

Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.

We deliver ingenious health solutions that enable people to live their best lives. Our Vision is clear: A better and healthier every day for every woman.

Estimated Salary Range: $160,000 - $200,000 per year

Job Description:

The Scientific Expert - Regulatory Affairs Leader will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects. The individual may also support project team goals and organizational initiatives as needed.

This role will involve oversight and monitoring of assigned CMC project timelines. The Scientific Expert - Regulatory Affairs Leader will work alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards achieving project goals.

This position will also be responsible for working with outsourced support of Network activities in alignment with the OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report, and act on delivery performance and quality of deliverables.

Responsibilities:

  • Manage processes and connections between external partners and various stakeholders within CMC.
  • Serve as the CMC Lead for assigned Global Network projects and be accountable for the delivery of all regulatory milestones.
  • Oversee preparation and submission of Global CMC dossiers for assigned Network projects.
  • Cultivate and foster collaborative relationships with internal and external partners to drive on-time high-quality delivery of business commitments.
  • Actively monitor facilitate report and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality on-time submission information.
  • Escalate potential delays or performance issues in a timely manner to impacted cross-functional stakeholders.
  • Manage communication and change management within the internal organization.
  • Provide CMC support for Legal Entity Change (LEC) project.

Required Education Experience and Skills:

  • Bachelor's degree in a science engineering or related field such as Pharmacy Chemical Engineering Biology Microbiology Virology Molecular Biology Biochemistry.
  • Or advanced degree (MS MBA Ph.D. PharmD) - minimum 4 years of relevant experience including biological pharmaceutical research manufacturing testing or a related field.
  • Strong negotiation interpersonal written/oral communication and fluent in English language.
  • Ability to lead by influence and work effectively in matrix organizational structures.
  • Project Management.
  • Good understanding of change management projects.

Preferred Education Experience and Skills:

  • Degree in pharmacy biopharmaceutics analytical chemistry organic chemistry chemical engineering or a related discipline.
  • Direct experience in Regulatory CMC.
  • Demonstrated experience driving change initiative projects.

Benefits:

As an equal opportunity employer Organon welcomes applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.


  • Scientific Liaison

    1 semana atrás


    Lisboa, Lisboa, Portugal Boehringer Ingelheim Portugal, Lda Tempo inteiro

    The ideal candidate for this role will have a strong scientific background and excellent communication skills.OverviewBoehringer Ingelheim Portugal, Lda is seeking a Medical Scientific Liaison to join our team in Portugal.Job DescriptionWe are looking for an experienced professional to act as a liaison between Health Care Professionals (HCPs), Clinical and...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job Title: Medical Science LiaisonJob Summary:Organon is seeking a Medical Science Liaison to join our team. As a Medical Science Liaison, you will be responsible for engaging in non-promotional, peer-to-peer communications and providing medical/scientific information to Scientific Leaders and Key Decision Makers. You will work throughout a product's...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job SummaryAs a Medical Science Liaison at Organon, you will play a critical role in engaging with Scientific Leaders and Key Decision Makers to provide medical and scientific information. With a strong background in life sciences and advanced scientific training, you will work closely with our medical team to ensure that our products are utilized...

  • Scientific Exchange Expert

    2 semanas atrás


    Lisboa, Lisboa, Portugal Gilead Sciences, Inc. Tempo inteiro

    Company OverviewGilead Sciences, Inc. is a biopharmaceutical company dedicated to discovering and developing innovative treatments for complex medical conditions.Salary$123,000 - $180,000 per annum, based on experience and qualifications.Job DescriptionWe are seeking a highly skilled Medical Scientist to join our team, responsible for providing scientific...


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    Job OverviewBiom?Rieux Bv is seeking a highly skilled Scientific Health Specialist to join our team. As an expert in the life sciences, you will be responsible for engaging with scientific leaders and key decision-makers to provide medical/scientific information.About the RoleThe ideal candidate will have a doctorate degree in the life sciences and extensive...


  • Lisboa, Lisboa, Portugal Boehringer Ingelheim Portugal, Lda Tempo inteiro

    Medical Scientific Liaison RoleThe Medical Science Liaison (MSL) acts as a bridge between Health Care Professionals (HCPs), Clinical and Scientific External Experts (EEs) and Boehringer Ingelheim in order to deliver and collect important scientific information. This role is key in sharing and gathering insights from scientific discussions, trial results...


  • Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Thermo Fisher Scientific, a leading global biotechnology company, is seeking an experienced Regulatory Affairs Specialist to join our Global Clinical Trial team. With a competitive salary of $120,000 per annum, this role offers a unique opportunity to contribute to the development and implementation of regulatory strategies for clinical trials...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job DescriptionKey ResponsibilitiesEngage in non-promotional, peer-to-peer exchange of medical and scientific information with healthcare professionals, patient associations, and other stakeholders.Represent Medical Affairs at local or regional non-promotional medical events, such as medical congresses and symposia.Provide insights on scientific gaps, ideas,...


  • Lisboa, Lisboa, Portugal Gilead Sciences, Inc. Tempo inteiro

    Job Description:As a Medical Scientist at Gilead, you will play a crucial role in responding to clinical inquiries regarding marketed or developmental products. Your primary responsibility will be to present scientific and clinical data for these products, establishing strong relationships with opinion leaders, clinical investigators, and providers in...


  • Lisboa, Lisboa, Portugal Takeda Tempo inteiro

    Job Title: Medical Scientific Liaison NORTHAbout the Role:We are seeking a highly skilled Medical Scientific Liaison to join our team in Porto, Portugal. As a Medical Scientific Liaison, you will be responsible for providing local country field-based support for medical plan implementation, identifying and developing strong sustainable peer-to-peer...


  • Lisboa, Lisboa, Portugal Inspired Education Group Tempo inteiro

    Job Opportunity at PaRK International SchoolWe are seeking a highly qualified and experienced Scientific Expert for Secondary Education to join our team at PaRK International School in Lisbon, Portugal. The ideal candidate will have a strong background in Physics and a valid teaching qualification, with experience teaching the subject at the secondary...


  • Lisboa, Lisboa, Portugal Takeda Tempo inteiro

    Medical Scientific Liaison NorthAre you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Scientific Liaison North in Porto, Portugal.Takeda is a global pharmaceutical leader with more than 50,000 professionals working...


  • Lisboa, Lisboa, Portugal Takeda Tempo inteiro

    About TakedaTakeda is a global pharmaceutical leader dedicated to improving people's lives through leading innovation in medicine. Our commitment to putting people first and living our values of Integrity, Fairness, Honesty, and Perseverance drives our mission to strive toward for people worldwide.Our Medical Scientific LiaisonWe are seeking a Medical...


  • Lisboa, Lisboa, Portugal Daiichi Sankyo Europe Tempo inteiro

    Job Title: Medical Expert Hematology PositionAbout the Role:We are seeking a highly skilled Medical Expert in Hematology to join our team at Daiichi Sankyo Europe. As a Medical Expert, you will be responsible for acting as the primary point of contact and local key scientific expert for Quizartinib and AML disease with internal and external stakeholders.Key...


  • Lisboa, Lisboa, Portugal Daiichi Sankyo Tempo inteiro

    Job SummaryAs a Medical Expert Hematology at Daiichi Sankyo, you will be responsible for acting as the primary point of contact and local key scientific expert for Quizartinib and AML disease with internal and external stakeholders in 'Country XYZ'.Main Responsibilities Communicate the scientific value of hematological products to internal and external...

  • Clinical Specialist

    4 semanas atrás


    Lisboa, Lisboa, Portugal Boston Scientific Gruppe Tempo inteiro

    About the RoleThe Electrophysiology Field Clinical Specialist will provide expert clinical product and technical assistance and training to physicians, Lab Staff, and sales representatives on the effective and safe use of the Farapulse system during case procedures within an assigned geography, and in a manner that leads to meeting and exceeding business...


  • Lisboa, Lisboa, Portugal Daiichi Sankyo Europe Tempo inteiro

    Job Title: Medical Expert Hematology SpecialistAt Daiichi Sankyo Europe, we are seeking a highly skilled Medical Expert Hematology Specialist to join our team. As a key member of our Medical Affairs department, you will play a crucial role in communicating the scientific value of our hematological products to internal and external stakeholders.Key...


  • Lisboa, Lisboa, Portugal Daiichi Sankyo Europe Tempo inteiro

    Job Title: Medical Expert Hematology SpecialistJob Summary: We are seeking a highly skilled Medical Expert Hematology Specialist to join our team at Daiichi Sankyo Europe. As a key member of our European Medical Affairs team, you will be responsible for communicating the scientific value of our hematological products to internal and external stakeholders.Key...


  • Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Job SummaryWe are seeking a highly experienced and skilled Lead Scientific Excellence Manager to join our team at Tn Portugal. As a key member of our Health Science department, you will be responsible for overseeing the scientific and technical capabilities globally, providing guidance to local, regional, and global teams, and contributing to the strategy...


  • Lisboa, Lisboa, Portugal Boehringer Ingelheim Portugal, Lda Tempo inteiro

    Company OverviewAt Boehringer Ingelheim, we strive to make a positive impact on people's lives through our innovative medicines and dedication to scientific excellence.We are a family-owned company with a rich history dating back to 1885, proud of our long-term perspective and commitment to the well-being of both humans and animals.SalaryThe estimated annual...