Sciences de la vie

Chargé(e) Affaires Réglementaires

Notre client, une entreprise innovante et grandissante spcéialisée dans les dispositifs médicaux recherche actuellement un(e) chargé(e) affaires réglementaires afin de rejoindre son équipe sur Genève pour une durée de minimum 6 mois.

 

VOS MISSIONS:

  • Rédiger les dossiers techniques de dispositifs médicaux.
  • Enregistrer à l’export les dispositifs médicaux en collaboration avec les partenaires locaux (préparation des dossiers, réponses aux questions des autorités de santé)
  • Gérer les modifications d’enregistrement /renouvellements en Europe et à l’export (élaboration de la stratégie réglementaire et rédaction des dossiers)
  • Assurer la veille réglementaire en lien avec l’activité
  • Assurer le rôle d’équipier projet affaires règlementaires dans le cadre de l’implémentation de la nouvelle règlementation européenne des dispositifs médicaux

VOTRE PROFIL:

  • Master en affaires réglementaires ou équivalent avec une expérience de minimum 3/5 sur un poste identique
  • Bonne connaissance des dispositifs médicaux, notamment sur la nouvelle réglementation.
  • Bonne communication et esprit d’équipe
  • Anglais courant

Pour plus de détail, merci de contacter Marine Dollat sur mdollat@axepta.com

Head of Formulation and Process Development

Head of Formulation and Process Development (oral/topic)

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton. Due to this growth my client is looking for a Head of Formulation and Process Development to lead activities of oral and topic products.

RESPONSABILITIES :

1-Operations :

       Design and lead specific formulation and manufacturing process development plan in cooperation external partner, in line with business priorities, following a Quality by Design framework

       Contributes for the conception, design, and interpretation of scientific and technical data to support projects decision making 

       Collaborates with others to solve complex problems, taking a new perspective on existing solutions

       Identify, technically qualify and recommend external partner (e.g. CDMO, Academia) and set strategic partnership (e.g. raw material suppliers, packaging suppliers)

       Provides and present data to internal project team meetings

       Function effectively as a core team member on multiple concurrent project developments

       Ensure close liaison with Operations to prepare, execute and support technical transfer to the late stage of development

       Communicate effectively within CMC Development Department, SIG Rx and beyond and with external partners (e.g. Suppliers, Vendors) and is able to defend scientific and technical decisions at the appropriate governance body / meeting

       Contribute to set a risk management table, update it as necessary and escalade in a timely manner any critical risk

       Plan efficiently activities and ensure strict monitoring of milestones and budget

       Act as a voice and ambassador of its department at various governance bodies / meetings

 

2-Regulatory Submissions, Documentations and Compliance :

 

       Author, review and/or approve key documents such as: formulation development reports, manufacturing process development report, technology transfer document, justification of in process controls, and relevant sections of regulatory filings (IND, IMPD, CTD)

      Author standard operating procedures and working instructions required by the activities

      Ensure that external partners operate in compliance with Safety, Health and Environment policy

       Contributes to the preparation of audits and inspections

 

3-Knowledge Management :

 

       Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact formulation and process development activities in close cooperation with CMC Development Expert

       Provides communication and training within the Organization

       Identify and attend congresses and forum to ensure continuous expertise growth and visibility of Galderma

       Publish/present in high quality journals/conferences

 

QUALIFICATION :

 

       PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10+ years of relevant experience in pharmaceutical industry

       Strong exprience with oral and topical developments, freeze-dried and sterile processes

       Experience working with external partners (e.g. CDMO, Academic)

       Strong experience with developing formulation strategy and manufacturing process engineering

       Excellent understanding of cGMP, ICH guidance and applicable guidelines

       In-depth knowledge how to implement a Quality by Design approach including design of experiment and statistical analysis

       Experience in authoring pharmaceutical development related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions

       Excellent communication, negotiation and external follow-up

       –       Excellent verbal and written communication skills (English)

Senior Clinical Project Manager Oncology

My client is an innovating, dynamic and niche international biopharma company currently expanding their clinical development team.

Due to this growth my client is looking for a Senior International Clinical Project Manager with strong Oncology experience on phase III to join them in Lausanne area.

 

Your responsibilities :

 

       Lead the overall initiation, coordination, implementation and management of large international Phase III clinical trials from start-up to close out.

       Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met;

       Manage operational and technical aspects of projects including budgeting, study initiation and risk management;

       Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation;

       Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required;

       Represent clinical operations on multi-function project teams internally and externally; report on study progress;

       Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans;

       Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents;

       Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc;

       Monitor vendor and CROs performance and ensure continuous oversight;

       Design, review and approve of all trial related documentation, and establish trial processes.

 

Your profile :

 

       University degree or equivalent in Life Sciences.

       Fluent in English – French is an asset

       Must have experience working in Oncology studies

       Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO.

       Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.

       Experience in management of CROs, vendors and consultants.

       Strong project management skills.

       Excellent budgeting, planning, and communication skills.

       Ability to lead and influence a cross-functional study team and external partners.

      Willingness to travel up to 30%

Responsable Qualité Facilités et Utilités Biopharma

Notre client, une entreprise biopharmaceutique située sur le canton de Vaud, recherche un Responsable Qualité Facilités et Utilités afin de prendre en charge les activités d’ingénierie d’assurance qualité associées à la conception, à la construction et au démarrage d’une nouvelle installation de bioproduction à grande échelle. Les responsabilités comprendront un support à la conception, à la qualification et à la validation lors de l’élaboration de la conception, des achats, des tests de réception en usine, de l’installation, de la mise en service et de la qualification de nouveaux systèmes et équipements de processus utilisés dans la production. Plus précisément, ce poste soutiendra toutes les activités de qualification et de validation des utilités, des installations et des systèmes CVC de fabrication de substances médicamenteuses biopharmaceutiques conformément aux politiques de qualité, aux normes cGMP et aux réglementations FDA suisses et européennes. Ce poste offre de belles perspectives dans le temps avec des responsabilités évolutives.

 

Vos Responsabilités :

 

       Agir en tant que point de contact pour toute la partie qualité compliance concernant les utilités (Hvac, WFI, PW, monitoring environnemental…)

       Travailler en tant que Project leader pour le design des délivrables concernant les installations et les utilités.

       Support pour l’évaluation des risques

       En charge de l’ensemble de la documentation des installations et des utilités (procédures, protocoles FAT/SAT, rapports de qualification, CAPAs, déviations, change controls)

       Assurer la qualification et la validation de tous les équipements en étroite collaboration avec les équipes d’ingénierie et d’automatisation des processus

       Travailler à tout moment sur le site de préparation aux inspections réglementaires (Swissmedic et International)

       Créer des SOP pour la qualification / validation des installations et des utilités

       Être un grand support pour la partie validation et qualification des installations et des utilités.

       Aider à la gestion des sous-traitants dans son scope

       Contribuer à mettre en place la culture d’Enterprise.

       Travailler en étroite collaboration avec les ingénieurs de production

       Aider à l’évolution de la qualité pour l’ensemble du site (CAPA, change controls, déviations)

 

Votre profil :

 

       Ingénieur en chimie, biochimie ou équivalent avec une expérience de minimum 5 ans sur un poste similaire.

       Grande expérience dans le domaine de la qualité et la validation et qualification des installations, utilités et système HVAC (double casquette qualité et qualification)

       Très bonne capacité de communication

       Très bonne connaissance du système qualité et des GMPs.

       Expérience avec les inspections des autorités de santé

       Français courant et anglais professionnel

       Capacité à prendre des décisions pragmatiques et orienté résultat

Responsable Qualité et Validation Biotech

Notre client, une entreprise biopharmaceutique située sur le canton de Vaud, recherche un Responsable Qualité Facilités et Utilités afin de prendre en charge les activités d’ingénierie d’assurance qualité associées à la conception, à la construction et au démarrage d’une nouvelle installation de bioproduction à grande échelle. Les responsabilités comprendront un support à la conception, à la qualification et à la validation lors de l’élaboration de la conception, des achats, des tests de réception en usine, de l’installation, de la mise en service et de la qualification de nouveaux systèmes et équipements de processus utilisés dans la production. Plus précisément, ce poste soutiendra toutes les activités de qualification et de validation des utilités, des installations et des systèmes CVC de fabrication de substances médicamenteuses biopharmaceutiques conformément aux politiques de qualité, aux normes cGMP et aux réglementations FDA suisses et européennes. Ce poste offre de belles perspectives dans le temps avec des responsabilités évolutives.

Vos Responsabilités :

       Agir en tant que point de contact pour toute la partie qualité compliance concernant les utilités (Hvac, WFI, PW, monitoring environnemental…)

       Travailler en tant que Project leader pour le design des délivrables concernant les installations et les utilités.

       Support pour l’évaluation des risques

       En charge de l’ensemble de la documentation des installations et des utilités (procédures, protocoles FAT/SAT, rapports de qualification, CAPAs, déviations, change controls)

       Assurer la qualification et la validation de tous les équipements en étroite collaboration avec les équipes d’ingénierie et d’automatisation des processus

       Travailler à tout moment sur le site de préparation aux inspections réglementaires (Swissmedic et International)

       Créer des SOP pour la qualification / validation des installations et des utilités

       Être un grand support pour la partie validation et qualification des installations et des utilités.

       Aider à la gestion des sous-traitants dans son scope

       Contribuer à mettre en place la culture d’Enterprise.

       Travailler en étroite collaboration avec les ingénieurs de production

       Aider à l’évolution de la qualité pour l’ensemble du site (CAPA, change controls, déviations)

 

Votre Profil :

       Ingénieur en chimie, biochimie ou équivalent avec une expérience de minimum 5 ans sur un poste similaire.

       Grande expérience dans le domaine de la qualité et la validation et qualification des installations, utilités et système HVAC (double casquette qualité et qualification)

       Très bonne capacité de communication

       Très bonne connaissance du système qualité et des GMPs.

       Expérience avec les inspections des autorités de santé

       Français courant et anglais professionnel

       Capacité à prendre des décisions pragmatiques et orienté résultat

Senior Expert Scientist In Vitro Pharmacology

 My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton. Due to this growth my client is looking for Senior Expert Scientist In Vitro Pharmacology to lead activities of in vitro biology and the analysis of the generated data necessary for the identification and the development of the future candidates.

 

Responsabilities :

       Participates in the definition of the strategic axes of the biology and in the choice and implementation of corresponding technological solutions for in vitro biology.

       Conducts interactions with CRO partners for all in vitro biology activities especially functional activities (3D, ex vivo etc. …).

       Supervises in vitro biology activities and analyzes the data generated in the research phases.

       Contributes to the evaluation and prioritization of projects in the Research portfolio

       Provides scouting, evaluation, and recommends opportunities for licensing and / or internalization of molecules and / or projects in the different phases of Research and Development.

       Participates in identifying future strategic direction

       Ensures the identification, selection and management of strategic collaborations of the Research Department

       Contributes to the management of the global research budget

       Contributes to maximizing the value proposition of Research and Development projects.

 

Expected Qualifications :

       PhD in Molecular or Cellular Biology.

       Post-doctorate in an academic or industrial environment – preferably abroad. 

       Academic training or acquired by the years in Research in the pharmaceutical industry and drug discovery.

       You have 10 years of minimum expertise in academic or industrial research in in vitro pharmacology associated with human health, as well as experience in conducting collaborative research programs with external partners

       You have a very strong expertise in in vitro pharmacology and in specific models especially 3D models; models on ex-vivo human skin.

       You have a proven track record of Multidisciplinary Team Leadership.

       You have a good knowledge of early clinical development as well as a good knowledge of skin biology and dermatological pathologies.

       You have demonstrated experience of effective partnership with CROs.

       Excellent teaching and presentation skills are expected as well as an excellent ability to work in a multicultural team.

       You have proven experience of project management.

       You speak and write English fluently. 

Senior Expert Scientist Toxicology

MMy client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.

Due to this growth my client is looking for Senior Expert Scientist Toxicology to carry out the toxicology evaluation and data analysis activities required to identify and develop future candidates

Activities and Responsabilties :

       Participates in the definition and organization of the in vitro and in vivo toxicology evaluation activities in the Research phases, necessary to guarantee a portfolio of innovative, competitive projects aligned with the strategy

       Participates in defining and implementing the technological solutions needed to implement the toxicology evaluation strategy

       Lead safety evaluation activities (in vitro and in vivo safety profiling) and analyzes the data generated.

       Participates in the analysis of the safety profiles observed and defines the safety margins of the clinical candidates.

       Participates in project evaluation and prioritization activities

       Provides scouting, evaluation, and recommends opportunities for licensing and / or internalization of molecules and/or projects in the different phases of Research and Development.

       Contributes to the management of the global research budget

       Contributes to the execution of strategic collaborations of the Research Department

       Contributes to the visibility of the company at international level (conferences, collaborations, KOL etc …).

 

Expected qualifications :

       PhD in Toxicology (ERT or DABT).

       Academic training or acquired by the years in Research in the pharmaceutical industry and drug discovery

       Post-doctorate in an academic or industrial environment – preferably abroad

       Specialization in pharmacology, immunology or pharmacokinetics

       You have 5-10 years of expertise in academic or industrial research in the field of pharmacology and in vitro toxicology, in vivo, multi animal species associated with human health research. Experience in pathology would be an advantage, but it is not required.

       You have a successful experience conducting collaborative research programs with external partners.

       You have a proven track record of Multidisciplinary Team Leadership.

       You have a good knowledge of pharmacokinetics and early clinical development

       Excellent teaching and presentation skills are expected as well as an excellent ability to work in a multicultural team.

       You speak and write English fluently.

Clinical Data Manager

My client is an innovating, dynamic and growing international medical device company currently expanding their clincal team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Clinical Data Manager.

Your Responsibilities :

 

Ø Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.

Ø Be in contact with the global authorities.

Ø Leverage EDC development outsourced to external partners and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with internal database (ie safety database)

Ø Act as EDC representative

Ø Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming

Ø Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.

Ø Manage user access to the clinical database. Ensure appropriate training is received.

Ø work closely with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.

Ø Participate in the development and maintenance of Data management SOPs.

 

Your Profile :

 

Ø Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;

Ø Minimum of 4 years of experience in clinical data management.

Ø Strong knowledge of CDISC standards is required ;

Ø Experience in biostatistics and/or SAS programming is a plus ;

Ø Strong critical thinking and problem solving skills ;

Ø Able to rapidly adapt to changing environment and circumstances ;

Ø Fluent in English and French.

Senior Medical Lead-Immuno-Inflammation

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Lausanne area.

Due to this growth my client is looking for a Senior Medical Lead with experience on Dermatology or Immuno-Inflammation therapeutic areas 

Responsabilities :

 

Ø Lead the medical communication plan aligned with global strategy

Ø Publication plan

Ø Scientific material production plan

Ø Medical training plan

Ø Scientific event (ad-boards and congresses) plan

Ø External expert engagement plan

Ø Scientific society engagement plan

Ø Patient organization engagement plan

Ø Promotional material review plan

Ø Medical review and approval of scientific content of promotional material and post submission regulatory documents.

Ø Responsibility for organizing scientific events (boards, symposia/medical events.

Ø Preparation and update of educational material for internal or external stakeholders.

Ø Leading the scientific exchanges with the medical community and building/strengthening the global external expert network.

 

Your profile :

 

Ø Medical Degree required, Dermatologist would be a plus

Ø At least 7-10 years in medical affairs at a global level in the pharmaceutical industry

Ø Fluent in English, written and oral 

Senior Expert CMC Biologics Development

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior CMC Expert/Director with experience working on Biologics Product.

Responsabilities :

 

Ø Contribute to the definition and the implementation of the CMC strategy in line with the overall strategy
Ø Provide expertise and leadership in the development, communication and implementation of global CMC strategy in support of product portfolio execution
Ø Ensure a balanced approach to pharmaceutical development risk, understanding the impact to the business and enabling smooth approval of regulatory submissions
Ø Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
Ø Review and approve CMC and quality documents (i.e. IND, CTA, BLA)
Ø Contribute to Quality by Design CMC development strategy (e.g Quality Target Product Profile).
Ø Act as POC of the Pharmaceutical Development Department in governance bodies and meetings
Ø Leverage the pharmaceutical expertise to proactively coordinate project cross functional CMC content, in close collaboration with Pharmaceutical Development Functions, external partners and Project Management
Ø Act as Pharmaceutical Development Representative in the Global Project Team
Ø Elaborate with the Heads of Function and SMEs a CMC project development plan including milestones, external costs and internal resources needs
Ø Elaborate with the Heads of Function and SMEs a risk management table, update it as necessary and escalade in a timely manner any critical risk
Ø Work closely with CMC Regulatory Affairs and ensure alignment regarding questions and strategies, driving development of science based argumentation to obtain buy-in of regulatory agencies, together with appropriate Heads of Function and SMEs
Ø Attend CMC meetings with Health Authorities (e.g. FDA, PMDA, EMA) and act as CMC representative
Ø Ensure liaison and coordination between Pharmaceutical Development Department and Operations
Ø Support external partner oversight and management of CMC Expertise
Ø Develop and nurture a network of CMC experts to support strategy
Ø Proactively contribute to implement regional regulatory requirements and guidelines that impact pharmaceutical development activities

Ø Maintain current awareness of regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future Development
Ø Communicate this within the Team and to other staff, as appropriate, and provide key strategic pharmaceutical development expertise inputs to projects and cross-functional teams
Ø May publish/present in high quality journals/conferences
Ø Lead working groups to develop internal policy or guideline

 

Your profile :

 

Ø Pharmacist, PhD, MS in biological sciences, biochemical engineering, or a related discipline, concentration in microbiology, biochemistry might be a plus
Ø Minimum 15 years experience in the pharmaceutical industry and 8-10 years in CMC expertise supporting worldwide product development in the related field
Ø Demonstrated understanding of CMC development in the field of biologics (e.g. cell culture, upstream and downstream process, analytical sciences including characterization and comparability studies, combination product,  technology transfer), including Quality by Design methodology
Ø Demonstrated experience in developing and implementing CMC work plans to support phase appropriate activities, including management of timelines and budget
Ø Strong knowledge in developing and implementing risk management
Ø Strong experience in authoring/reviewing regulatory documents (e.g. IND/IMPD, BLA) and in supporting registration process
Ø Demonstrated ability to set CMC strategy and to interact with competent authorities
Ø Effective leadership, project management, interpersonal skills
Ø Excellent verbal and written communication (English)
Ø Ability to lead and promote changes
Ø Ability to solve complex problems and to propose innovative solutions
Ø Demonstrated knowledge of cGMP requirements

Senior Biostatistician

My client is an innovating, dynamic and niche international privately-owned biopharma company currently expanding their Statistic team in Switzerland, Lausanne area. Due to this growth my client is looking for a Senior Biostatistician to join their team.

YOUR RESPONSABILITES :

 

Ø Provide statistical programming expertise

Ø Coordinate all statistical programming related tasks.

Ø Works closely with all departements and CRO for all statistical programming related activities, including development and validation of ADaM.

Ø Create derived data set specifications for all assigned studies and integrated summaries.

Ø Review statistical analysis plans for all assigned studies and integrated summaries and provide comments to study biostatistician.

Ø Review annotated case report forms and provides comments.

Ø Contribute to process improvement initiatives as assigned.

 

YOUR PROFIL :

 

Ø Master’s or Bachelor Degree in Statistics,Computer Science, with an experience of minimum 5 years  in pharmaceutical industry.

Ø Strong SAS programming language

Ø Strong knowledge of CDISC Standards

Ø Good understanding in statistical methods used in statistical analysis.

Ø Good knowledge within GCP

Ø Fluent in English

 

Senior Medical Affairs Lead Dermatology

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Medical Lead with experience on Dermatology or Immuno-Inflammation therapeutic areas.

 

Senior Medical Affairs Lead Dermatology

 

Responsabilities :  

  

Ø Lead the medical communication plan aligned with global strategy

Ø Publication plan

Ø Scientific material production plan

Ø Medical training plan

Ø Scientific event (ad-boards and congresses) plan

Ø External expert engagement plan

Ø Scientific society engagement plan

Ø Patient organization engagement plan

Ø Promotional material review plan  

Ø Medical review and approval of scientific content of promotional material and post submission regulatory documents.      

Ø Responsibility for organizing scientific events (boards, symposia/medical events.

Ø Preparation and update of educational material for internal or external stakeholders.

Ø Leading the scientific exchanges with the medical community and building/strengthening the global external expert network.  

 

Your profile :

 

Ø Medical Degree required, Dermatologist would be a plus

Ø At least 7-10 years in medical affairs at a global level in the pharmaceutical industry

Ø Fluent in English, written and oral

Medical Writer

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Medical/Scientific Writer.

The position will report to the Head of Clinical Development Department.

 

Your Responsabilities :

       Prepares and finalises clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, summary documents, RMPs (initial and updates), regulatory responses, and briefing documents. Documents must be of high quality in terms of scientific content, as well as organisation per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency;

       Leads cross-functional document planning and review meetings

       Leads in a team environment with greater independence for longer-term activities, and takes a lead role on assigned projects concerning timing, scheduling, and tracking;

       Indirectly or directly leads or sets objectives for others on team projects and tasks; e.g., able to lead process working groups;

       The primary point of contact for Clinical Development Team for medical writing activities;

       Responsible for functional planning and metrics database updates for assigned program.

 

Your Profil :

       PhD or Master in elated Pharmaceutical Science with minimum 3 years experience of relevant regulatory medical writing

       Ability to function (and potentially lead) in a team environment;

       Demonstrates learning agility ;

       Builds solid and productive relationships with cross-functional team members;

       Strong project management skills

       Strong leadership skills

       Fluent in English and French

Assistant Réglementaire

Notre client, une entreprise spécialisée dans les dispositifs médicaux et en pleine croissance actuellement, recherche un(e) assistant(e) réglementaires afin de renforcer son équipe affaires réglementaires.

Ce poste sera basé sur Genève et pour une durée de 6 à 9 mois.

Vos Responsabilités :

       Participer à l’enregistrement des produits auprès des autorités de santé avec les chefs de projet réglementaires

       Préparer des documents administratifs, gestion de demandes de légalisations et demandes de traductions.

       Préparation des échantillons de produits.

       Archiver la documentation.

       Participer à la gestion des articles de conditionnement et documents promotionnels.

       Archiver des bons à tirer.

       Créer une base de données des fichiers source en collaboration avec le rédacteur technique.

       Effectuer le suivi du budget, gestion des réservations des déplacements de l’équipe, gestion de l’archivage de la documentation du département, gestion de la mise à jour des outils de suivi de l’activité, gestion des abonnements aux revues.

       Proposer des axes d’amélioration, en termes d’organisation des tâches administratives.

 

Votre Profil :

       Profil administratif avec une 1 ère expérience professionnelle confirmée

       Anglais courant

       Expérience en affaires réglementaires

       Connaissance du milieu Life Science.

Senior Expert Scientist

My client is an innovating, dynamic and niche international privately-owned biopharma company currently expanding their Drug Discovery team in Switzerland, Lausanne area. Due to this growth my client is looking for a Senior Expert Scientist Drug Discovery to join their Translational Medicine team.

 

Responsibilities :

Ø Work in a matrix organization in close collaboration with other Translational Medicine functions (DMPK, Preclinical Safety and Diagnostics/Personalized Medicine) to characterize the pharmacological properties of our drug candidates

Ø Represents the Translational Pharmacology function in the Translational Medicine Project Teams May represent the Translational Medicine function in the global Project Teams and lead a Translational Medicine Project Team (core team member).

Ø Manages laboratory-to-human research in Contract Research Organizations: designs, monitors, and reports the primary and secondary pharmacology studies performed

Ø In vitro/in vivo pharmacology compounds selection and profiling, including off target characterization Proof of concept in vivo studies – PK/PD

Ø Identification, method development/validation of clinical pharmacodynamic (PDy) biomarkers Defines and manages the clinical translational PDy analyses (incl. blood and tissue biomarkers), data analyses and reporting according to GCPs and GCLPs

Ø Supports and advises the Clinical Research and Development team

Ø Contributes to the preparation of the pharmacology regulatory documentation (IDB, summaries for IND and IMPD, briefing documentation)

Ø May participate in interactions with Health Authorities.

 

Your profile :

 

Ø PhD in relevant expertise area or equivalent in biomedical engineering

Ø Minimum 5 years of experience in Translational Pharmacology Research and drug development Experience working in oncology projects is a must

Ø Experience in the pharma industry

Ø In-depth knowledge in translational research in personalized oncology and basic knowledge of related disciplines including histopathology, bioanalytics, pharmacokinetics and PK/PD

Ø Project management experience and strong communication and presentation skills

Ø Fluent in English

Life Science Recruiter

Société Axepta SA à Genève, recherche un Recruteur expérimenté en recrutement Life Science pour venir renforcer notre équipe dans le département Life Science. Spécialiste en Recrutement Life Science

Responsabilités :

Ø  Recrutement à 360° dans le domaine de l’industrie Life Science sur la Suisse Ø  Travailler en étroite collaboration avec les clients afin de comprendre les exigences d’embauche et les besoins futurs

Ø  Placer des annonces dans les marchés pertinents, publications et emploi

Ø  Présélection des candidats et évaluation de leurs compétences

Ø  Réalisation d’entretiens téléphoniques et/ou rencontre avec les candidats Ø  Comprendre les exigences des clients et utiliser celle-ci comme un outil de promotion 

Ø  Promouvoir les tâches et les avantages de chaque poste

Ø  Prises de références, vérification des expériences professionnelles et les diplômes universitaires des candidats.

Ø  Mise à jour de la base de données avec les détails des candidats et des clients potentiels

Ø  Accompagnement des candidats pour la préparation des entretiens. Ø  Développement commercial auprès des entreprises

Ø  Rencontre avec les clients dans leurs bureaux

Ø  Conseiller les clients sur le marché, taux de rémunération, formation et perfectionnement professionnel.

Ø  Travailler en étroite collaboration avec les autres collègues dans le renforcement de la réserve actuelle de candidats ou dans la recherche de candidats proactives pour les postes critiques

Ø  Assister à des conférences et salons pour promouvoir la société

Ø  Développement de la base de données et de réseau de clients et contacts.

 

Qualifications :

 

Ø  Diplôme en ressources humaines, administratif ou équivalent.

Ø  Expérience professionnelle minium de 1 à 2 ans dans le recrutement dans le domaine du life science (pharmaceutique, Medical Device ou Healthcare)

Ø  Maîtrise du Français et de l’anglais (oral et écrit).

Ø  Expérience avec MS Office (MS Word, Excel, Outlook et PowerPoint) • Autonome et esprit d’équipe

Ø  Excellentes aptitudes à la communication et aux relations interpersonnelles

Ø  Le candidat doit avoir une attitude positive, proactive et une éthique élevée

Ø  Capable de prendre des initiatives pour s’assurer que les tâches sont accomplies en temps opportun

Senior Global Brand Manager-Inflammation and Immunology

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton. Due to this growth my client is looking for a Senior Global Brand Manager to join their strategic marketing department in Immunology and Inflammation and to be responsible for the development and implementation of the global marketing strategy and execution for current and future pipeline products.

 

Responsibilities:

 

Ø Working very closely with the Franchise head, and the Global Franchise Team

Ø Develop and refine the global marketing strategy, based on strong product value propositions addressed to key stakeholders to ensure successful commercialization

Ø Prepare product positioning, patient and prescriber segmentation and key marketing messages Ø Together with the Global Franchise team, develop communication strategies to support value messages.

Ø Work very closely with the global pricing and market access teams to define successful access strategies in key markets

Ø Work closely with the key affiliates to understand the market requirements and prepare global solutions that can be implemented at local level.

Ø Prepare the pre-launch market

Ø Assess the field force requirements and ensure launch readiness for successful launch of biologics Ø Develop all aspects of product branding

Ø Prepare logistics aspects (packaging, production planning …)

Ø Prepare all launch media (campaign, PR, digital …).

Ø Coordination of all scientific and medical communications of brands / products.

Ø Pricing guidelines and market access data in collaboration with the market access and regional marketing team

Ø Leading the congress activities from marketing perspective (booth, messaging, visuals etc) Ø Coordinates the marketing advisory board meetings

Ø KOL development (national and regional)

Ø Monitoring the financial performance of brands / products.

 

Your profile:

 

Ø Ideally double science training (engineer, pharmacy or medicine) and degree Business School.

Ø At least 7-10 years of global marketing experience in a pharmaceutical prescription industry

Ø Deep understanding on the requirements of global commercialization of biologic products, ideally with experience in dermatology

Ø Knowledge on requirements of US and key European markets

Ø Experience in global transversal projects