Senior Manager Scientific Affairs (m/f/d)

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

  • Assures availability and oversight of professional medical writing expertise to enable clinical document development like study protocols, briefing books,  submissions as well as rapid response team readiness.

  • Serves as the central point of contact for medical writing vendors and regulatory affairs and coordinates activities within the clinical team.

  • Prepares draft concept sheets and outlines of submission dossier storylines.

  • Builds and develops together with the Senior Director center of excellence for clinical trial disclosure, clinical modules, agency responses and literature.

  • Stays abreast of professional information and technology to augment expertise in the clinical development area with focus on biosimilars.

  • Ensures adherence to GCP and pharmacovigilance standards related to clinical development administrator role at clinicaltrials.gov for the biosimilar business and trials coordinator at other registries.

  • Prepares, oversees budget and invoices for clinical medical writing activities Supports medical writing vendor selection in all aspects as needed (RFPs, bid processes etc).

Education and work experience:

  • Natural science education within biology, biotechnology, medical or similar.
  • Bachelor level as minimum, PhD is an advantage.
  • At least 5 years of clinical development including medical writing experience in the pharmaceutical industry, academia, or equivalent.
  • Experience with briefing books, dossier preparation etc. is desired.

Job Specific Competencies & Skills:

  •  Ability to identify the key elements necessary for the clinical parts of a dossier and essential clinical documents.
  • Ability to work and cooperate in cross-functional global teams in a matrix environment.
  • Ability to interact with external and internal stakeholders to understand clinical document frameworks for regulatory agencies.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.
  • Knowledge in overseeing clinical writing activities including clinical trial disclosure according to expected format and quality Ideally experience with both, FDA and EMA dossiers.

Languages:

Excellent oral and written English communication skills.

Work experience:

At least 5 years of clinical development including medical writing experience in the pharmaceutical industry, academia, or equivalent. Experience with briefing books, dossier preparation etc. is desired.

  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Forschung & Entwicklung
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • International / Eysins
  • Bewerbungsfrist:
  • none - we look forward to your application
Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 45114

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Senior Manager Scientific Affairs (m/f/d)

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Your assignments

  • Assures availability and oversight of professional medical writing expertise to enable clinical document development like study protocols, briefing books,  submissions as well as rapid response team readiness.

  • Serves as the central point of contact for medical writing vendors and regulatory affairs and coordinates activities within the clinical team.

  • Prepares draft concept sheets and outlines of submission dossier storylines.

  • Builds and develops together with the Senior Director center of excellence for clinical trial disclosure, clinical modules, agency responses and literature.

  • Stays abreast of professional information and technology to augment expertise in the clinical development area with focus on biosimilars.

  • Ensures adherence to GCP and pharmacovigilance standards related to clinical development administrator role at clinicaltrials.gov for the biosimilar business and trials coordinator at other registries.

  • Prepares, oversees budget and invoices for clinical medical writing activities Supports medical writing vendor selection in all aspects as needed (RFPs, bid processes etc).

Your profile

Education and work experience:

  • Natural science education within biology, biotechnology, medical or similar.
  • Bachelor level as minimum, PhD is an advantage.
  • At least 5 years of clinical development including medical writing experience in the pharmaceutical industry, academia, or equivalent.
  • Experience with briefing books, dossier preparation etc. is desired.

Job Specific Competencies & Skills:

  •  Ability to identify the key elements necessary for the clinical parts of a dossier and essential clinical documents.
  • Ability to work and cooperate in cross-functional global teams in a matrix environment.
  • Ability to interact with external and internal stakeholders to understand clinical document frameworks for regulatory agencies.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.
  • Knowledge in overseeing clinical writing activities including clinical trial disclosure according to expected format and quality Ideally experience with both, FDA and EMA dossiers.

Languages:

Excellent oral and written English communication skills.

Work experience:

At least 5 years of clinical development including medical writing experience in the pharmaceutical industry, academia, or equivalent. Experience with briefing books, dossier preparation etc. is desired.

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 45114

Karrierelevel
Berufserfahrene
Einsatzbereich
Forschung & Entwicklung
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
International / Eysins
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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