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Clinical affairs manager • koln

Zuletzt aktualisiert: vor 2 Tagen
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Senior Medical Writer

Senior Medical Writer

Barrington JamesCologne, North Rhine-Westphalia, Germany
I'm partnered with a a pioneering biopharmaceutical company advancing personalised cell & gene therapies for life-threatening diseases. This role is an opportunity to be a part of the future of cell...Mehr anzeigenZuletzt aktualisiert: vor 8 Tagen
Medical Science Liaison, North Germany

Medical Science Liaison, North Germany

Exact SciencesCologne, North Rhine-Westphalia, Germany
At Exact Sciences were helpingchange how the world prevents detects and guides treatment for cancer.We give patients and clinicians the clarity needed to make confident decisions when they matter m...Mehr anzeigenZuletzt aktualisiert: vor 19 Tagen
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Global Head Medical Affairs

Global Head Medical Affairs

Medella LifeCologne , DE
Lead, manage and develop a best-in-class, high-performance medical writing, medical affairs team and related support functions. .Provide strategic direction to the Executive Leadership Team and Boar...Mehr anzeigenZuletzt aktualisiert: vor 19 Tagen
Central Academic Affairs Manager – Academic Operations (m / w / d)

Central Academic Affairs Manager – Academic Operations (m / w / d)

Galileo Global EducationKöln - Brüderstraße 17 | 50667
Macromedia gehört zur internationalen Bildungsgruppe Galileo Global Education.Erklärtes Ziel ist, jungen Menschen aus aller Welt unabhängig von ihrer Ausgangssituation Zugang zu höheren Bildungsabs...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Senior Clinical Research Associate

Senior Clinical Research Associate

AL SolutionsCologne , DE
Senior Clinical Research Associate – Germany (Home-Based, French Speaking).Chloe O’Shea is pleased to be working with a small global CRO recognised for driving innovation and excellence in clinical...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Clinical Scientist - Manager / Senior Manager (m / f / d)

Clinical Scientist - Manager / Senior Manager (m / f / d)

Tubulis GmbHCologne , DE
As a Clinical Scientist (m / f / d) and member of our Clinical Development team, you will support the planning and execution of full life-cycle development of our antibody-drug conjugates (ADCs) global...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Medical Science Liaison

Medical Science Liaison

Advanced ClinicalCologne , DE
Clinical Trial Educator – Europe.Biopharmaceutical / Clinical Development.This position offers the opportunity to work directly with leading investigators and study sites, helping to ensure excelle...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Regulatory Affairs Manager - Produktzulassung / Compliance / Strategie (m / w / d)

Regulatory Affairs Manager - Produktzulassung / Compliance / Strategie (m / w / d)

Workwise GmbHCologne, DE
Über uns Über OSYPKA GmbHSeit unserer Gründung im Jahr 1977 setzen wir bei der OSYPKA GmbH immer wieder Meilensteine in der Medizintechnik – mit Leidenschaft, Pioniergeist und einem klaren Ziel : Me...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Global Head of Pharmacovigilance

Global Head of Pharmacovigilance

BioTalentCologne , DE
BioTalent are delighted to partner with a rapidly growing biotech client, dedicated to transforming cancer treatment, currently hiring for a Global Head of Pharmacovigilance.This is a strategic lea...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Head of Global Supply Chain

Head of Global Supply Chain

Planet PharmaCologne , DE
A leading player in the biopharmaceutical industry is seeking a Head of Global Supply Chain Management to oversee and optimize the end-to-end supply chain for its growing biosimilar portfolio.This ...Mehr anzeigenZuletzt aktualisiert: vor 9 Tagen
Ultrasound Clinical Application Specialist

Ultrasound Clinical Application Specialist

Shanghai BSF Human Resources Co., LtdKöln, North Rhine-Westphalia, Germany
My client is a globally renowned leader in the medical tech space focusing on ultrasound solutions.With a team of top - tier professionals it creates a diverse range of ultrasound devices from high...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager (m / f / d)

Regulatory Affairs Manager (m / f / d)

GULP – experts unitedCologne
Es ist Zeit für den nächsten Karriereschritt? Gehen Sie ihn mit uns! Im Namen eines Geschäftspartners aus der .Regulatory Affairs Specialist . Auf Sie wartet eine attraktive .Bewerben Sie sich jetzt...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Junior Regulatory Affairs Manager Medical Devices – Export (m|f|d)

Junior Regulatory Affairs Manager Medical Devices – Export (m|f|d)

Miltenyi BiotecBergisch Gladbach, North Rhine-Westphalia, Germany
As a Junior Regulatory Affairs Manager you will actively support the registration of medical devices in our Export regions specifically in countries managed by distributors with a focus on LATAM C...Mehr anzeigenZuletzt aktualisiert: vor 29 Tagen
Clinical Application Specialist

Clinical Application Specialist

Zoll GmbHCologne, North Rhine-Westphalia, Germany
Quick Apply
Mit Kunden in mehr als 140 Ländern erweitern wir ständig unsere Reichweite und unser Produktangebot.Krankenhäuser, Rettungsdienste und andere Einrichtungen vertrauen auf unsere hochwertigen Produkt...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Clinical Data Manager (m|f|d)

Senior Clinical Data Manager (m|f|d)

Miltenyi BiomedicineBergisch Gladbach,
Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies.We are pioneering groundbreaking therapies for serious life-threatening diseases, and...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
Student Assistant Product ("Hiwi", m / f / d)

Student Assistant Product ("Hiwi", m / f / d)

Vivalyx GmbHCologne, North Rhine-Westphalia, Germany
Quick Apply
We, Vivalyx, are a medical technology startup from Aachen dedicated to saving people suffering from organ failure.Our goal is to significantly increase the vitality and number of donor organs.The c...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Global Regulatory Affairs Team LeaderNonStop Consulting

Global Regulatory Affairs Team LeaderNonStop Consulting

NonStop ConsultingNorth Rhine-Westphalia, Germany
Homeoffice
Global Regulatory Affairs Team Leader.Our client, a global leader in agricultural solutions, is seeking a highly experienced Regulatory Affairs Team Leader to join their dynamic team in North Rhine...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Clinical Research Associate (Home-Based) - Clinical Research Coordinator Experience

Clinical Research Associate (Home-Based) - Clinical Research Coordinator Experience

MedpaceCologne , DE
Medpace is a full-service clinical contract research organization (CRO).We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.Our mi...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Spezialist Produktsicherheit und Zulassung (m / w / d)

Spezialist Produktsicherheit und Zulassung (m / w / d)

persona service AG & Co. KG • Niederlassung : Köln SülzKöln, DE
Du bringst Erfahrung und Fachwissen mit – wir die passenden Perspektiven.Bei persona service erwarten Dich abwechslungsreiche Aufgaben, ein professionelles Umfeld sowie Unternehmen, die Dein Know-h...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
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Senior Medical Writer

Senior Medical Writer

Barrington JamesCologne, North Rhine-Westphalia, Germany
Vor 8 Tagen
Stellenbeschreibung

I'm partnered with a a pioneering biopharmaceutical company advancing personalised cell & gene therapies for life-threatening diseases. This role is an opportunity to be a part of the future of cell and gene therapy working with an innovation focused clinical development team.

Responsibilities :

  • Lead the creation, authoring, review and finalisation of clinical and regulatory documentation (CTD modules, clinical study reports, investigator brochures, INDs / IMPDs, NDAs / MAAs, briefing documents)
  • Ensure all documents are scientifically robust, strategically aligned, and fully compliant with global regulatory standards
  • Manage document timelines, orchestration of internal reviews, on-time delivery and alignment across cross-functional teams (clinical operations, regulatory affairs, biostatistics, safety)
  • Mentor and oversee a team of medical writers, participate in recruiting and onboarding junior writers, and ensure quality and regulatory integrity across deliverables

Your Profile

  • Relevant life science degree
  • 5+ years of experience in medical / regulatory writing
  • Comprehensive knowledge of ICH guidelines, global regulatory requirements and standards for QMS in writing and document control
  • Proven track record in authoring key submission documents (MAA / BLA / CTA) and experience in advanced therapy medicinal products, oncology / hematology or autoimmune domains is highly advantageous
  • Leadership experience including mentoring, team-management in medical writing or QARA roles
  • Excellent project management skills, ability to translate complex scientific data into clear regulatory narratives, fluent in English and comfortable working in a fast-paced international environment

    • For more information please contact ajenkins@barringtonjames.com