Sciences de la vie

Senior Regulatory Affairs Manager – Cosmetics

My client is an innovating, dynamic and growing international consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior Cosmetics RA Manager to plan and manage overall regulatory affairs strategy.

You will contribute to the global coordination of cosmetics for regulatory aspects for worldwide registration

Duties and Responsibilities
• Setting up the regulatory strategy for projects under development
• Contribute to defend RA strategy in dedicated forum
• Cooperate with affiliates in order to perform a feasibility analysis of projects roll out WW based on regional/national regulations
• Coordinate the preparation and participate to meetings with Health Authorities/Notified Bodies if necessary
• Communication of project relevant RA information to Project Team and Department Heads
• Represent RA for cosmetics in global & cross functional meetings
• Provide regulatory support to ensure the content of dossier/PIF is compliant with relevant regulations and is sufficient for submission/notification
• Update PIF periodically or upon specific request
• Ensure regulatory support for new product launch
• Maintain and track RA activities databases
• Support the development of labelling and artworks for cosmetics
• Act as deputy RA Head upon request

Work Experience
• 7 years min. of prior experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices)
• Mature interpersonal, communication and organizational skills.

Education and Training
• Master or any equivalent advanced scientific degree in a related technical field.
• Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

 

Please send your CV to Jean de La Fournière at jean@axepta.com

Regulatory Information Management System Manager (RIMS)

 

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 Regulatory Information Management System Manager (RIMS).

 

Responsabilities:

  • Maintain RIMS in a compliant and validated state
  • Provide direction and best practices to external provider
  • Establish and coordinate training strategy for end users
  • Interface with Operations to assure data sharing with ERP systems
  • Establish KPIs to measure RIMS data quality/usage
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Optimize and simplify the process of handling and tracking post approval changes transformation project
  • Maintain SOPs, instructions … related to RIMS.
  • Propose/implement process improvements

 

Requirement:

  • Regulatory affairs processes and EU registration procedures
  • Regulatory Information Management systems (Register™ preferred)
  • 5+ years of prior regulatory experience
  • Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
  • Strong IT skills, particularly in relation to using databases
  • Fluency in English

Ingénieur Assurance Qualité

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années recherche actuellement un Ingénieur Assurance Qualité afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

 

VOS MISSIONS:

– Être le garant de la mise en place de la nouvelle réglementation MDR au sein du département qualité.

– Travailler en étroite collaboration dans le cadre de la mise en place de cette réglementation.

– Effectuer un suivi quotidien des actions mise en place dans le cadre de la réglementation MDR.

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Gérer différent projet qualité

 

VOTRE PROFIL:

– Ingénieur ou pharmacien avec une expérience de minimum 3 ans dans le domaine des dispositifs médicaux.

– Une bonne connaissance de la nouvelle réglementation MDR serait un plus

– Expérience dans la gestion de projet d’amélioration continue

– Très bonne communication

– Anglais courant

– Être fort de proposition

 

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

Senior Clinical Project Manager – Pharma – English Fluent – Vaud canton

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

Due to this growth my client is looking for a Senior Clinical Project Manager to plan and manage overall clinical operations for assigned global clinical trials/programs.

You will serve as a project team member and coordinate the overall clinical program activities with other functions (e.g. RA, CMC) including long-term, next stage planning and may supervise other CPMs as part of the overall clinical program.

 

Activities and responsibilities:

Plan and conduct Clinical Studies:

  • Responsible for leading and managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
  • Responsible for the development of the Clinical Trial Outline and Clinical Protocol.
  • Ability to manage complex phase 3 clinical trial programs.
  • Manages selection of study vendors for assigned studies.
  • Manages vendor(s) throughout the life of assigned clinical trial(s).
  • Selects investigational sites with input from Clinical Development and vendors.
  • Reviews and refines Clinical Operations Plans including monitoring and other plans.
  • Works with clinical supplies to determine IP requirements.
  • Works with operations to oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs.
  • Provide input and contribute to the other study related documents.
  • Works with outsourcing manager and clinical team to establish budget and timelines for the study.
  • Plans and conducts investigator meetings, training sessions and KOL meetings as required.
  • Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.
  • Works with CS, ME and project team as appropriate to develop the Clinical Study Report.
  • Identifies and provides solutions to clinical trial issues or risk.
  • Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethic Committee/IRB.
  • Mentors staff and serves as a resource for new employees.
  • Provides or facilitate training to clinical study teams on protocol specific topics.
  • Participates as appropriate in internal and external audits.
  • Manages communication of study status and guidance to internal stakeholders.
  • Manage the Clinical Trial registry (clinical.trial.gov).
  • Manage the lesson learn meeting.
  • Manage subcontractors (CROs, experts …):
  • Works with Outsourcing manager to prepare Clinical outsourcing specifications.
  • Participate in the selection of CRO.
  • Review the CRO contract including scope of services.
  • Supervise adherence to scope of work within timelines and budget.

Quality and process:

  • Contribute and initiate process improvement initiatives.
  • Collaborate with other department members to promote harmonization of all processes and procedures.
  • Involve in documents quality control.

Budget and planning:

  • Establish project milestones and establish budget and timelines for the study conduct together with the study team.
  • Establish a detailed planning of clinical project.
  • Build, follow-up and close out study Budget following internal templates and instructions and according to the initially approved budget.
  • Follow-up closely the recruitment rate of the study and take appropriate corrective actions, if needed.
  • Make a risk assessment of the study and update it on a regular basis.
  • Track all aspects of the Clinical Trial and make regular progress reports.
  • Develop communication through newsletters to inform investigators and/or affiliates.
  • On a regular basis, update management with project milestones, costs, and projections for future activity (be able to provide various scenario/proposal/actions)

Project Team Representative (PTR):

  • Participate in the overall project planning, optimization and consolidation with the Project Team.
  • Works closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the Project.
  • Report progress on deliverables to the Project Team and identify variances and present solutions/alternatives.
  • Responsible and accountable for Operational aspects of the clinical project in terms of timelines, costs and resources.
  • Proactively evaluates risks at operational level and builds alternatives or contingency plans for discussion and arbitration within the Project Team.

Expected qualifications:

  • University degree, preferably in a biologic/scientific discipline
  • Minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent with Pharma/Biotech and/or CRO
  • Systemic route of administration clinical trials experience required; paediatric, drug/device combination and biologics experience preferred.
  • Thorough understanding of country level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
  • Ability to travel 30%

 

Please send your CV to Jean de La Fournière: jean@axepta.com

Senior Clinical Research Associate – English fluent – Pharma – Vaud

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

Due to this growth my client is looking for a Senior Clinical Research Associate has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study teams. You will work in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You may oversee regular CRA activities including contract CRAs.

 

Summary of responsibilities:

  • Oversees clinical trial set up including site selection and set-up.
  • Coordinates the overall interaction with clinical study sites and monitor CROs/site activities.
  • Key contributor to site identification and site selection.
  • Manages site closure activities of assigned sites with CRO.
  • Ensures quality and compliance with relevant regulatory standards according to procedural documents, international guidelines such as ICH and GCP as well as relevant local regulations.
  • Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.
  • Ability to manage a phase 1 or small phase 2 clinical trial.
  • Review protocol for operational feasibility and organize feasibility studies to ensure appropriate country selection.
  • Lead and coordinate the selection of investigators and ensure that the appropriate selection process has been utilized.
  • In collaboration with the CPM, make recommendations for the appropriate outsourcing of any required functions (e.g. monitoring, laboratory services etc.) and participate in the preparation of the related documentation.
  • Assist the CPM with the preparation of bid grids, budgets and significant study milestones.
  • Establish country and/or site-specific recruitment targets with internal / External CRAs and CPM to meet timelines.
  • In collaboration with line function manager and CPM, participate in CRO and other third-party vendor selection; assist with the review of proposals and attend bid defenses as required.
  • Development and/ or review of assigned study documentation (e.g. Protocol, ICF, Monitoring Plan, eCRFs).
  • Coordinate and/or organize technical training at investigator meetings, CRO/CRA training meetings.
  • Ensure that all regulatory approvals have been obtained before initiation visits are conducted & that the appropriate documentation is available.
  • Ensure that appropriate documentation is available to the investigators in a timely manner.
  • Ensure that clinical trial supplies are made available to investigators along with any other materials required by the protocol.
  • Participate in the set-up & user testing (UAT) of any systems used during a study e.g. eCRF/EDC, IRT, central laboratory portals etc. This includes review of relevant vendor documentation (system specifications, validation etc.).
  • Manage, track and document CRO CRA activities by reviewing monitoring reports, tracking on-site visit frequency, organization of on­ site quality control visits as appropriate.
  • Be responsible for and hold CROs accountable for contracted tasks relating to data monitoring and site quality.
  • Track recruitment and take appropriate steps to ensure recruitment targets are met; ensure Clinical Project Manager is fully informed & collaborate with CPM to identify issues, trends, resolutions and/or corrective actions.
  • Track, measure and report any deviations versus the planned timetable; identify the causes and provide solutions.

 

Work Experience:

  • Minimum of 5 years progressive relevant clinical experience in clinical operations including 3 years as Clinical Research Associate or equivalent with Pharma/Biotech and/or CRO.
  • Drug/device combination and biologics experience preferred.
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
  • Excellent knowledge of relevant local regulations.
  • Good understanding of the drug development process.
  • Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.

 

Education/Training:

University degree, preferably in life sciences or equivalent qualification

Please send your CV to Jean de La Fournière: jean@axepta.com

Medical Marketing Manager

Senior HCP Marketing Manager

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global Marketing team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior HCP Marketing Manager with good experience in communication with Healthcare providers especially with skincare.
In this challenging and dynamic role, you will contribute to change the way the world thinks about skin health by leading the development of Global healthcare professional strategies.
You will play a key role to strengthen the understanding among healthcare professionals on what skincare products can do to improve the health of the skin of their patients/customers.

Responsibilities:
• Will lead the development of the Global HCP strategy, Global communication campaigns for healthcare professionals as well as scientific communication to be delivered to markets.
• Will provide expert scientific dermatology knowledge to develop new products as well as compelling science-based communication messages.
• Deliver knowledge with support and alignment of Medical Expert and Claim Coordinator (CM): Own the HCP section in the SWOT analysis and in the brand innovation strategy and implementation, deliver scientific rationale behind consumer concepts and Claims, Integrate and align scientific inputs from local markets
• Lead the development of the HCP strategy and toolkit (with the input of experts): manage agencies from start to finish, Gather inputs from relevant stakeholders throughout the process, Perform toolkit deployment and train the local Medical affairs or local representatives, Organize scientific/medical expert meetings with the participation of Medical Expert and Claim manager
• Set up, leading and delivering scientific communication in partnership with CM and Medical Expert (posters, publications)
• Member of project team: Provide HCP inputs whenever required and represent Scientific and Medical voices in the project team. Coordinate cross functional alignment with local Medical Affairs, Global Clinical Operations, Medical Expert
• Lead and coach global brand manager(s); implement all people related processes (performance management, talent selection and development, compensation review etc.) to develop and reward direct reports
• Represent brand with HCPs during congresses, symposiums, etc.

Your profile:
• Nutritionist / Dermatologist / pharmacist background with master in Marketing
• More than 10 years experience in HCP marketing management in the FMCG/FMCH industry in cosmetics / dermatology and matrix organization at a local ,regional and global level
• Successful track record of working in a matrix organization and managing diverse teams.
• Thought leader in different lifecycles of brands (incl. ideation, launch and sales)
• Thought leader in turning medical concepts / stories & claims into HCP and consumer centric concepts and claims to help support business initiatives
• Thought leader in building strategies and assets to drive connectivity with target consumers via HCP influencers (from KOL to pharmacy assistant)
• Combination of consumer centric business acumen and scientific savviness
• Proficiency in English

For more details, please contact Jean de La Fournière mailto:jean@axepta.com

Pharma Regulatory Affairs Submission Associate

 

Core Mission

To support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products (prescription drugs) mainly for international countries (excluding US) and  ad-hoc support for European countries.

 

Activities and responsibilities

  • Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
  • Assure timely receipt and dispatch of administrative documents and their legalization (if applicable) necessary for registration, renewal and variation files (including but not limited to Certificate of Pharmaceutical Products, Free Sale Certificates, Letter of Authorization, GMPs, Price certificates)
  • Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update

 

Work Experience

  • 1-2  year’s experience in regulatory affairs, ideally in a global organization for international countries such as Middle East, CIS or Latin America
  • Experience in a multinational environment
  • Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database

 

Required Skills and Knowledge

  • BSc in Scientific or equivalent experience
  • Planning, organizing and time management skills
  • ability to deal with rapid change
  • Fluent in English; French and/or Spanish is a plus

Please send your CV to Jean de La Fournière at jean@axepta.com

Pharmaceutical Regulatory Affairs – Publishing specialist

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

Due to this growth they are looking for a Regulatory Affairs Publishing and eCTD specialist to join them on a permanent contract.

Responsibilities:

  • Supporting Publishing and EDMS (Electronic Document Management System) users
  • Business Administrator for Publishing and EDMS systems
  • Archiving Submission Dossiers
  • Provide training and support for Publishing and EDMS users
  • Manage related training materials
  • Perform Business Administration activities for Publishing and EDMS
  • Archive Submission Dossiers and ensure their traceability across systems
  • Interface with Coordinators from Consumer and Aesthetic SIGs and with IT team
  • Support writing of procedures, instructions, user guides
  • Ad interim, could act as delegate of the Publishing coordinator for outsourced activities

Your profile:

  • BSc, MSc in scientific, IT or administrative discipline or equivalent experience
  • Minimum 3 years’ experience Pharmaceutical Industry
  • Minimum 2 years’ in similar role

Please send your application to Jean de La Fournière: jean@axepta.com

Post Market Surveillance – Medical Devices

Job Description

Responsiblities

  • Act as interface between product surveillance and regulatory, Quality, Clinical R&D, and Marketing team to gather appropriately PMS data.
  • Ensure the interface between the Safety department and other services within the company (R&D, Clinical, Marketing, Regulatory Affairs and Quality)
  • Participate in the development of cross-functional document planning and review meetings
  • In connection to R&D and Clinical team,analyze, adapt and translate technical information related to products into medical information suitable for the marketing team
  • Collect, trend and escalate data related to Post marketing Surveillance
  • Develop PMS plans, PMCF plans, PSURs, and PMCF reports
  • Participate to the development of the CER
  • Regulatory watch: PMS, clinical, MD vigilance,Medical Affairs
  • National health authorities website surveillance,including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence(performance and safety vs competitors)
  • Track competitors data performance (clinical studies) and safety (vigilance)
  • Ensure that post marketing procedures, processes and documentation meet the regulations in all subsidaries
  • Participation in the activities of risk management in connection with the customer complaint process (map, tables and risk management)
  • Develop the risk management process with R&D-CA-RA-MA interfaces, and user table point of contact
  • Participation on various committees (Change Board,CAPA Board, Risk Board, Quality Committee)
  • Follow-up to the NCF, changes and CAPA inconnection with medical affairs
  • Participation in the improvement of processes,procedures, instructions, forms, tools and database in relation to the activities of the Medical Affairs Department
  • Participation to Audits

Secondary activities:

  • Respect the safety rules and apply the instructions in force,
  • Report all situations of risk to her manager or co-workers,
  • Do not expose his colleagues in situations of danger,
  • Use the measures of protection of collective and individual required foractivity

 

KNOWLEDGES and SKILLS required:

Minimum level of training and/or professional experience required by the function:

  • Scientific training
  • Experience in the Medical Device industries
  • QSM and risk management skills
  • French and English, another language an asset
  • Good writing and communication skills
  • Control of Pack Office

Job Type: Full-time

Please send your application to Jean de La Fournière: jean@axepta.com

Chargé d’Affaires Réglementaires – CDD 6 mois

VOS RESPONSABILITÉS:

  • Rédiger les dossiers techniques des dispositifs médicaux
  • Enregistrer à l’export les dispositifs médicaux du laboratoire 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)
  • Être un support pour les chefs de projets, notamment par rapport au projet MDR en assumant des activités sur la zone export.
  • Assurer la veille réglementaire en lien avec l’activité

VOTRE PROFIL:

  • Master en affaires réglementaires ou autre
  • Min. 6 mois d’expérience en affaires réglementaires
  • Connaissance de la norme ISO13485 et du nouveau règlement
  • Expérience en export
  • Anglais courant.

Envoyez votre candidature à Jean de La Fournière: jean@axepta.com

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