Sciences de la vie

Senior Clinical Research Scientist Immuno-Oncology

My client is a growing international pharmaceutical company based in the French part of Switzerland with ongoing growth. Due to this growth, my client is looking for a Senior Clinical Research Scientist to work with the physicians and other members of the Clinical Team to provide clinical research support for programs in Immuno-Oncology.

Responsibilities :

Ø  Development of protocols for clinical studies

Ø  Preparation of clinical development plans

Ø  Drafting of clinical scientific documents such as IND, IND amendments Investigator Brochures, Annual Reports and other FDA submissions

Ø  Monitor, review and summarize safety and efficacy data in ongoing studies

Ø  Assist with study design for exploratory development

Ø  Will lead the clinical matrix teams for assigned compounds

Ø  Develop relationships with appropriate consultants

Ø  Write abstracts and present data at scientific meetings, both internally and externally

Ø  Serve as liaison to project teams, CRO’s and others

 

Your profile :

 

Ø  Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred

Ø  Minimum of 4 to 6 years of experience in research with at least 3 or more years of drug development experience are preferred

Ø  Prior Immuno-Oncology/ Oncology Drug Development experience

Ø  Ability to multi-task and work in a fast-paced environment

Ø  Excellent written and oral communication skills

Ø  Strong Analytical ability

Ø  Oral and Written proficiency in English

Regulatory Affairs Expert

Our client, a growing and global niche medical device company, is looking for a Regulatory Affairs Expert to join there team in canton de Vaud.

Regulatory Affairs Expert

RESPONSABILITIES :

Ø Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.

Ø Review analytical data from development studies, performance evaluation studies, and clinical field trials to ensure regulatory requirements are met.

Ø Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.

Ø Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications worldwide.

Ø Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.

Ø Assist with the implementation of the Company’s Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standards, the 98/79/EC, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.

 

PROFIL :

Ø Master degree or equivalent diploma in science (Master Degree in Biology, Biochemistry, Immunology, Virology or related field)

Ø A minimum of 5 years of experience in regulatory within the combination products, biologics products or medical device products.

Ø Previous experience in bringing an new product to market, significant experience of Design Control

Ø Previous experience filing: BLA, PMA, 510(k)

Ø Ability to interface with regulatory authority and analyse technical information in a structure many to be able to prepare coherent regulatory files

Ø Ability to work in a multicultural team environment

Ø Fluent in English

Ø This role will require International Travels less than 20%

Senior Project Leader Cosmetics

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 Project Leader with experience working on Consumer Cosmetics Skin care Product. In this challenging and dynamic role, you will be part of the Global

Program Management team and will report to the Global Program Manager.

 

Responsibilities :



Ø  Manage one or several Innovation projects with high impact on business;

Ø  Manage the project end to end (from Pre-ideation to Launch in main market);

Ø  Interact proactively with the other functions, especially the business lead and operations to ensure the overall project objectives.

Ø  Deliver product(s)/process(es)/system(s)/solution(s) with defined quality at defined time and cost; • Contribute to the future commercial success of the business by considering the whole picture of the project;

Ø  Effectively control scope changes through proactive and open communication with stakeholders;

Ø  Plan the End-to-End project with project team contribution and ensure adequate resources and competence levels.

Ø  Manage budget within allocated envelop

Ø  Facilitate and coach within the project team and enhance the interaction and collaboration between the various experts and external partner

Ø  Seek and apply best practices in ways of working (processes, data analysis and decisionmaking in the project team). Your profile :

Ø  PhD, MD, PharmD Sciences or equivalent;

Ø  Full proficiency in English;

Ø  Minimum of 10 years of experience in Cosmetic development, operations and corporate functions • Minimum of 5 years project management experience;

Ø  Demonstrate the courage and ability to solve problems;

Ø  Proven communication skills (e.g. presents confidently and convincingly to steering committees);

Ø  Has experience in Innovation process or similar;

Ø  Proven FMCG experience or similar experience in cosmetic industry;

Ø  Entrepreneurial mindset (creative thinking and innovation);

Responsable Gestion des Risques et CAPA

Notre client, une entreprise spécialisée dans les dispositifs médicaux dans la région de Genève recherche actuellement un responsable CAPA et Gestion des risques afin de compléter son équipe (création de poste).

 

Responsable Gestion des Risques et CAPA

 

VOS RESPONSABILITES :

 

Ø  Piloter et coordonner le déploiement opérationnel de la politique de gestion des risques de l’établissement (Produits, Processus, Partenaires, Etudes Cliniques, SI, …) conformément aux procédures applicables.

Ø  En relation avec les managers internes, garantir la conformité des référentiels de maîtrise des risques avec les exigences et les réglementations en vigueur.

Ø   S’assurer de la cohérence des analyses menées (Criticité et mesures de maîtrise des risques) et de l’efficacité des mesures mises en œuvre

Ø  Apporter sa contribution aux réflexions visant à abaisser le niveau de risques de l’établissement (criticité, probabilité, détectabilité)

Ø  Piloter et coordonner le processus CAPA

Ø  Participer aux inspections et revues de direction

 

Ø  Assister le responsable Assurance Qualité sur tous les aspects liés à l’analyse des risques et aux CAPA

 

VOTRE PROFIL :

 

Ø  Ingénieur ou Pharmacien avec minimum 5 ans d’expérience sur un poste similaire dans le domaine Pharmaceutique ou des dispositifs médicaux

Ø  Bonne connaissance de la norme ISO 14971 et de la mise en place de CAPA

Ø  Bonne vision globale pour la mise en place de la gestion de risques et la définition de la stratégie.

 

Ø  Anglais professionnel

Senior Global Brand Manager-Pharma

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

Ø Good written and oral communication skills in English

Medical Writer

 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 Medical Writer with experience working on global level.

YOUR RESPONSIBILITIES :

Ø Produce documents to support clinical trials and regulatory submissions, in accordance with international regulations and guidelines

Ø Research and recommend external partners, and monitor the quality and progress of sub-contracted writing activities.

Ø Contribute to updating SOPs and templates managed by Scientific Writing, and interface with other departments for process fine-tuning.

Ø Liaised with multi-disciplinary teams to drive the CTD 

Ø Created and developed various regulatory documents

Ø Lead the initiative to develop guidance document for trial results disclosure activities

 

YOUR PROFILE

 

Ø At least 7 years scientific/medical writing experience in the pharmaceutical industry.

Ø Expertise in clinical eCTD submissions (NDA, BLA)

Ø Excellent scientific/medical writing skills.

Ø Excellent understanding of biostatistics.

Ø Excellent communication skills.

Ø Expert knowledge of regulatory requirements for global submissions.

Ø Proven ability to manage CRO writing activities.

Ø Experience of process improvement initiatives (updating SOPs, templates etc.)

Ø Excellent written and spoken English, french is a must

Senior Project Leader Cosmetics

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 Project Leader with experience working on Consumer
Cosmetics Skin care Product.
In this challenging and dynamic role, you will be part of the Global Program Management team and
will report to the Global Program Manager.

Responsibilities :

Ø Manage one or several Innovation projects with high impact on business;
Ø Manage the project end to end (from Pre-ideation to Launch in main market);
Ø Interact proactively with the other functions, especially the business lead and operations to ensure the overall project objectives.
Ø Deliver product(s)/process(es)/system(s)/solution(s) with defined quality at defined time and cost;
Ø Contribute to the future commercial success of the business by considering the whole picture of the project;
Ø Effectively control scope changes through proactive and open communication with stakeholders;
Ø Plan the End-to-End project with project team contribution and ensure adequate resources and competence levels.
Ø Manage budget within allocated envelop
Ø Facilitate and coach within the project team and enhance the interaction and collaboration between the various experts and external partner
Ø Seek and apply best practices in ways of working (processes, data analysis and decisionmaking in the project team).

Your profile :

 

Ø PhD, MD, PharmD Sciences or equivalent;
Ø Full proficiency in English;
Ø Minimum of 10 years of experience in Cosmetic development, operations and corporate functions
Ø Minimum of 5 years project management experience;
Ø Demonstrate the courage and ability to solve problems;
Ø Proven communication skills (e.g. presents confidently and convincingly to steering committees);
Ø Has experience in Innovation process or similar;
Ø Proven FMCG experience or similar experience in cosmetic industry;
Ø Entrepreneurial mindset (creative thinking and innovation); 

Assistant Qualité

Notre client, une entreprise spécialisée dans les dispositifs médicaux, recherche actuellement un(e) assisant(e) qualité afin de renforcer son équipe sur Genève pour une mission de minimum 9 mois.

Cette personne aura l’occasion de travailler dans le département QA et QC.

VOS MISSIONS:

  • Participer à la rédaction de documents qualité, diffusion et archivage.
  • Participer aux activités administratives pour les équipes AQ/CQ (ex: gestion des réservations        pour les déplacements de l’équipe, note de frais, mise à jour des outils de suivi de l’activité,            facturations)
  • Participer à la préparation des dossiers de reconditionnement (impression notice, diffusion           des informations, mise en forme du dossier)
         Etre un support pour l’ensemble de l’équipe qualité

 VOTRE PROFIL:

  • Employé de commerce / Diplôme en administration ou diplôme dans le domaine                              pharmaceutique avec une expérience significative dans le domaine Lifescience et si                      possible en qualité.
  • Minimum 5 ans d’expérience sur un poste similaire
  • Anglais professionnel.
  • Bonne communication et présentation

 

Responsable Gestion des Risques et CAPA

Notre client, une entreprise spécialisée dans les dispositifs médicaux dans la région de Genève recherche actuellement un responsable CAPA et Gestion des risques afin de compléter son équipe (création de poste).

       VOS RESPONSABILITES :

  • Piloter et coordonner le déploiement opérationnel de la politique de gestion des risques de l’établissement (produits, processus, partenaires, études cliniques, SI, …) conformément aux procédures applicables.
  • En relation avec les managers internes, garantir la conformité des référentiels de maîtrise des risques avec les exigences et les réglementations en vigueur.
  • S’assurer de la cohérence des analyses menées (Criticité et mesures de maîtrise des risques) et de l’efficacité des mesures mises en œuvre.
  • Apporter sa contribution aux réflexions visant à abaisser le niveau des risques de l’établissement (criticité, probabilité, détectabilité)
  • Piloter et coordonner le processus CAPA
  • Participer aux inspections et revues de direction
  • Assister le responsable Assurance Qualité sur tous les aspects liés à l’analyse des risques et aux CAPA

       VOTRE PROFIL :

  • Ingénieur ou Pharmacien avec minimum 5 ans d’expérience sur un poste             similaire dans e domaine Pharmaceutique ou des dispositifs médicaux
  • Bonne connaissance de la norme ISO 14971 et de la mise en place de CAPA
  • Bonne vision globale pour la mise en place de la gestion de risques et la définition de la stratégie.
  • Anglais professionnel

CMS IT Project Manager

CMS IT Project Manager

 

Activities and responsibilities :

 

Ø Responsible for the planning, coordination and delivery of IS/IT projects: 

Ø Facilitate the definition of project scope, goals and deliverables;

Ø Define project tasks and resource requirements;

Ø Develop full scale project plans;

Ø Assemble and coordinate project staff;

Ø Manage project budget;

Ø Manage project resource allocation;

Ø Track project deliverables using appropriate tools;

Ø Manage project risks and issues

Ø Perform project reviews

Ø Provide direction and support to project team;

Ø Present project status reports

Ø Implement and manage project changes and interventions to achieve project outputs;

Ø Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion;

Ø Identify and resolve issues and conflicts within the project team

Ø Identify and manage project dependencies and critical path;

Ø Proactively manage changes in project scope, identify potential crises, and devise contingency plans

Ø Ensure the validation of GxP systems is executed in coherence with the project plan

 

Profile requirement 

 

Recruitment profile :

 

Ø Degree : Master degree or equivalent with a specailization in IT or information system. PMP Certification.

Ø Professional experience: A 10 year professional experience in managing complex IT projects. Experience of working in Pharma industry (GxP) or another regulated industry. Experience of working in global organizations with virtual teams.

 

Requirements for this position :

 

Ø Good understanding of application components and translation into functional and technical requirements

Ø Strong project management and planning skills including experience in successfully managing major projects with use of and adherence to structured methodology;

Ø Ability to act as a trusted business partner by building long-term relationships;

Ø Strong influencing skills and ability to work across businesses and functions

Ø Fluent in English, French a plus

Ø Knowledge of agile project management methodology a plus.