Life Science

Head of Global Regulatory Affairs Skin Care/Cosmetics

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

 

Due to this growth my client is looking for a Head of Global Regulatory Affairs with experience working on Skin Care/Cosmetics Products at global level including US and ASIAN market.

 

Responsibilities:

  • Ensure that regulatory strategy follows local and international regulatory requirements for skin care products and OTC products
  • Represent the company in Health Authorities ‘meetings
  • Lead and Manage a Regulatory Affairs team
  • Ensure professional development of individuals
  • Act as Global regulatory representative
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current regulation
  • Bring strong expertise in regulatory affairs on cosmetics

 

Your profile:

  • Lifescience Degree, Master or any equivalent advanced scientific degree in a related technical field.
  • Minimum 10 to 15 years of Experience in global Regulatory Affairs with strong experience in the Consumer Care environment (Skin Care/Cosmetics).
  • Leadership, direct management, mature interpersonal, communication and organizational skills, direct and mobilize team around common goals and objectives, manage through efficient delegation, encourage and support individual’s development
  • Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

Please send your application to noliva@axepta.com 

Global RA Head

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 Global RA Head to manage a team and ensure best regulatory strategy in compliance with local and international regulatory requirements for OTC drugs and more generally consumer products

 

YOUR RESPONSIBILITIES:

 

  • Management of RA submisssion-team and set priorities according business needs and managerial considerations
  • Act as Global regulatory representative Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements
  • Represent the company in Health Authorities‘ meetings
  • Ensure professional development of individuals
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current Regulation
  • Ensure regulatory intelligence and initiate modifications of formulations when needed
  • Bring strong expertise in regulatory affairs on cosmetics (EU regulation 1223/2009 but not limited )
  • Work closely with different departments (marketing, safety, toxicology, BD,..)
  • Work closely with external partner

 

 

YOUR PROFILE:                   

  • PhD or Master in Science or equivalent with minimum 15 year experience in a similar position.
  • Prior experience in global Regulatory Affairs including few years in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices).
  • Knowledge and management record of frontier products category.
  • Strong experience in management of a big blockbuster brand across international US and Asia (japan/Korea)
  • Strong experience in team management
  • Strong leadership
  • Fluent in English
  • Mature interpersonal, communication and organizational skills.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Global RA Senior Manager

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 Global RA Senior Manager to manage a team and ensure best regulatory strategy in compliance with local and international regulatory requirements for OTC drugs and more generally consumer products

 

YOUR RESPONSIBILITIES:

 

  • Act as Global regulatory representative of OTC products Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements
  • Represent the company in Health Authorities‘ meetings
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current Regulation
  • Ensure regulatory intelligence and initiate modifications of formulations when needed
  • Work closely with different departments (marketing, safety, toxicology, BD,..)
  • Work closely with external partner

 

 

YOUR PROFILE:                   

  • PhD or Master in Science or equivalent with minimum 7 year experience in a similar position.
  • Strong experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices)
  • Strong experience with external partner
  • Strong experience in team management
  • Fluent in English
  • Mature interpersonal, communication and organizational skills.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior HCP Marketing Manager Skin Care

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 care 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

Senior Global Project Manager- Biologics

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

 

Due to this growth my client is looking for a Senior Project Manager to provide day-to-day project management leadership to global drug development project teams in the innovation and pharmaceutical strategy group.

Responsibilities:

  • Work closely with the Head Project Management and Global Program Leaders to establish and maintain project plans and budgets, organize and lead project team meetings, foster communication and coordinate between functional groups, ensuring adequate resourcing to meet goals, identifying risks and mitigations and providing updates on project status to project team leaders to ensure the timely supply of quality products to their patients.
  • Create and maintain integrated product development plans that reflect core objectives, minimize risk, and deliver results.
  • Manage global, cross-functional, complex drug development project teams/sub-teams and provides advanced project management support, including action item tracking, organization and communication of materials
  • Organise interdepartmental activities to ensure completion of assigned projects within scope, on schedule and within budget constraints
  • Identify, monitor, and analyse business project risks and prepares project planning contingency scenarios.
  • Ensure accurate tracking and reporting of project milestones and deliverables
  • Prepare project updates for governance meetings and clearly communicates status in written documents and presentations
  • Ensure documentation of, and access to, key project documents, presentations and data
  • Assume full responsibility for managing specific aspects of the project as designated by team leadership.

Your profile:

 

  • BA/BS is required; advanced degree (MBA) is a plus
  • Minimum 10 years of relevant experience in experience in a Biopharma or Biotech environment with at least 7 years of experience in Project Management
  • Self-directed, process oriented and able to work well in a team environment
  • Thorough understanding of the drug development processes
  • Hands-on expertise with project management tools (e.g. Planisware)
  • Good understanding of financial and resource planning systems and processes and ability to coordinate project level budget/resource estimates and manage actuals vs. plan
  • PMP certification would be an advantage
  • Fluent in English is a must

 

Please find send your application to noliva@axepta.com

VP of Clinical Services

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a VP of Clinical Services to join one of their office in Ulm Area, Germany and manage full service Clinical CRO division.

 

Responsibilities:

 

  • Responsible for all operational and strategic aspects of the design and implementation of clinical trial services, overall client satisfaction and divisional profitability
  • Supervise and develop 6 Departmental Heads to assure high quality Service delivery.
  • Leading, guiding and inspiring approx. 80 employees, through your Clinical Services

team (Clinical Conduct and Medical Services in our Phase I CPU, Clinical Laboratory,

Project Management, Data Management, Biostatistics, Medical Writing,

Regulatory Affairs and Monitoring Services)

  • Supervise ongoing projects and assure their performance with respect to quality

standards (SOPs, ICH-GCP), contract and timelines

  • Responsible for the divisional P&L, with oversight of the clinical program budget

across the portfolio

  • Providing active support and participation in client acquisition and contracting in

close collaboration with Business Development and the other divisional leaders.

  • Assure a continuous communication between the project team and client for an

effective study performance, respecting administrative and regulatory authority matters, ensuring client satisfaction

  • Further development and improvement of the divisional organization including

structure, processes and systems with the objective of process efficiency, quality

enhancement and margin optimization

  • Fostering an environment supporting innovation and smart risk-taking in Clinical

Services to help the division continuously evolve and improve.

 

Your profile:

 

  • PhD or equivalent in Life Sciences (medicine or healthcare discipline preferred)
  • 15+ years of experience in Clinical Development, particularly in Early Development,

preferably in both Pharma and CRO, with at least 10 years of project and/or line

management experience in a Clinical CRO

  • Knowledge and experience in planning, conducting and reporting of clinical trials,

including practical experiences in Project Management, Clinical Operations and at

least a solid understanding of Data Management, Biostatistics and Pharmacovigilance.

  • Experience of leading a large operational team and effecting change
  • Strong financial acumen with a solid understanding of proposal and contract generation, operational and margin growth and budget management
  • Proven track record of succeeded business growth
  • Leadership and hands-on management, influencing skills, high personal initiative

and team spirit, commitment, and accountability

  • Distinct organizational, problem-solving and analytical skills
  • Excellent English skills oral and written, and at least a basic understanding of German.

 

Director 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 Director 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 :

 

  • Development of protocols for clinical studies
  • Preparation of clinical development plans
  • Drafting of clinical scientific documents such as IND, IND amendments Investigator Brochures, Annual Reports and other FDA submissions
  • Monitor, review and summarize safety and efficacy data in ongoing studies
  • Assist with study design for exploratory development
  • Will lead the clinical matrix teams for assigned compounds
  • Develop relationships with appropriate consultants
  • Write abstracts and present data at scientific meetings, both internally and externally
  • Serve as liaison to project teams, CRO’s and others

 

Your profile:

 

  • Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred
  • Minimum of 4 to 6 years of experience in research with at least 3 or more years of drug development experience are preferred
  • Prior Immuno-Oncology/ Oncology Drug Development experience
  • Ability to multi-task and work in a fast-paced environment
  • Excellent written and oral communication skills
  • Strong Analytical ability
  • Oral and Written proficiency in English

Please send your application to noliva@axepta.com 

PMS Specialist

My client is an innovating, dynamic and growing international medical device company currently expanding their team in Switzerland, Geneva canton. Due to this growth my client is looking for PMS Specialist to join there regulatory affairs’s team.

YOUR RESPONSIBILITIES:

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 the 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 Teoxane 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 in connection 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

YOUR PROFILE:

  • Master in regulatory affairs or equivalent with minimum 3/5 years experience in a similar position
  • Strong knowledge with medical devices 
  • Strong knowledge with QSM and risk management
  • Fluent in  English (speak and write)

For more details, please contact Marine Dollat at mdollat@axepta.com

Global Brand Director Immuno-Inflammation

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 Global Brand Director 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:

 

  • Working very closely with the Franchise head and the Global Franchise Team
  • Develop and refine the global marketing strategy, based on strong product value propositions addressed to key stakeholders to ensure successful commercialization
  • Prepare product positioning, patient and prescriber segmentation and key marketing messages
  • Together with the Global Franchise team, develop communication strategies to support value messages.
  • Work very closely with the global pricing and market access teams to define successful access strategies in key markets
  • Work closely with the key affiliates to understand the market requirements and prepare global solutions that can be implemented at local level.
  • Prepare the pre-launch market
  • Assess the field force requirements and ensure launch readiness for successful launch of biologics
  • Develop all aspects of product branding
  • Prepare logistics aspects (packaging, production planning …)
  • Prepare all launch media (campaign, PR, digital …).
  • Coordination of all scientific and medical communications of brands / products.
  • Pricing guidelines and market access data in collaboration with the market access and regional marketing team
  • Leading the congress activities from marketing perspective (booth, messaging, visuals etc)
  • Coordinates the marketing advisory board meetings
  • KOL development (national and regional)
  • Monitoring the financial performance of brands / products.

 

Your profile:

 

  • Ideally double science training (engineer, pharmacy or medicine) and degree Business School.
  • At least 7-10 years of global marketing experience in a pharmaceutical prescription industry
  • Experience working on Chronic Diseases
  • Deep understanding on the requirements of global commercialization of biologic products, ideally with experience in dermatology
  • MUST have experience launching products in the US and key European markets
  • Experience in global transversal projects
  • Good written and oral communication skills in English

Please send your profiles to noliva@axepta.com  

Senior Expert Drug Design

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 Drug Design to contribute for the design and evaluation of future oral and topical drug.

 

YOUR RESPONSABILITIES:

 

  • Contributes to the implementation of the future Drug Design strategy axes and ensure the strategy for outsourcing choices (CRO, university,..) that best correspond to strategic choices.
  • Participates to the evaluation and prioritization of projects
  • Ensures the implementation of partnerships and technological solutions 
  • Leads to the design and evaluation of innovative molecules for future drug candidates in collaboration with CROs, for oral and topical projects.
  • Leads collaboration with CRO partners for all design components of future drug candidates for portfolio projects.
  • Ensures to maximizing the value proposition of Research and Development projects.
  • Contributes to maintain an innovative and competitive research project portfolio
  • Contributes to the management of the global research budget of SIG Rx.
  • Contributes to the visibility of the company at international level (conferences, collaborations, KOL etc. …).


YOUR PROFILE:

  • PhD in Organic Chemistry or PhD in Medicinal Chemistry with minimum 10 years experience in Drug Design
  • Strong knowledge in biology, pharmacokinetics, silico modelling techniques, the drug discovery process and team management.
  • You have demonstrated an experience of innovation and significant achievement in the field of Drug Design as well as in the field of systemic, oral or injectable medicines.
  • You have conducted collaborative research programs with external partners.
  • You have good knowledge of fields biology/therapy areas and pathologies.
  • You have good knowledge of the development processes and early clinical development in particular
  • Excellent teaching and presentation skills are expected, as well as an excellent leadership capacity with a multicultural and multidisciplinary team.
  • You have gained international recognition for your work (conferences, publications, patents).
  • You speak and write English fluently.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Regulatory Affairs Publishing and eCTD specialist

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 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

 

 

 

Electronic Document Management System Manager (EDMS)

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 an Electronic Document Management System Manager to join them on a permanent contract.

 

Responsibilities:

 

• Responsible of the Global Regulatory EDMS (Electronic Document Management System)
• Manage Regulatory requirements and define business processes
• Coordinate with IT support and/or service providers as needed

• Responsible to maintain Global Regulatory EDMS in a compliant and validated state
• Maintain/develop the application and related processes
• Ensures maintenance and business support of the system
• Interface with key users from R&D departments (Regulatory, Clinical, Pre-Clinical …)
• Interface with IT for technical support
• Coordinate/Implement training program for end users
• Lead/Organize Computer System Validation (CSV) activities
• Lead User Teams and Governance Board
• Maintain SOPs, instructions related to EDMS.
• Propose/implement process improvements

• Propose/participate in steps required to maintain regulatory compliance

 

Your profile:

 

· Degree in IT or Scientific or equivalent

· Minimum 8 years experience in Pharmaceutical Industry

· Minimum 5 years in similar role in IT, Clinical or Regulatory departments

· Strong experience with EDMS (Documentum/D2 preferred)

· Experience with Computer system validation (CSV)

 

 

Regulatory Information Management System Manager

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 to join them on a permanent contract.

 

Responsabilities :

  • Manage RIMS application in compliance with regulatory requirements.
  • Managing the Regulatory Information Management System (RIMS) for all products
  • Maintaining optimal interface with Global and Local Regulatory Affairs team members
  • Coordinating with IT support and external service providers
  • Interface with Coordinators to support function for all products.
  • Propose/animate/manage evolution of application to improve efficiency and to ensure continued regulatory compliance.
  • Manage training support for new users.
  • Monitor data entry compliance.
  • Propose/manage corrective action plans, if necessary.
  • Write SOPs, forms, etc. to describe the day-to-day operations of function.
  • Propose/implement process improvements
  • Monitor internal and Professional communications  concerning relevent regulations (ICH, FDA, EMA …)
  • Propose/participate in steps required to maintain regulatory compliance

 

Your profile :

  • BSc, MSc in scientific, IT or administrative discipline or equivalent experience
  • 5 years experience Pharmaceutical Industry
  • 3-5 years in similar role
  • Experience of managing service providers.
  • Regulatory affairs processes and EU registration procedures
  • Regulatory Information Management systems (Register™ preferred)
  • Computer System Validation (CSV)
  • Fluent in English

 

Senior Safety Advisor Cosmetics

My client is an innovating, dynamic and growing international pharmaceutical company in Switzerland, Vaud Canton. Due to this growth my client is looking for Senior Safety Advisor cosmetics to lead activities of safety and toxicology aspects for raw materials and finished products.

Senior Safety Advisor Cosmetics

YOUR RESPONSABILITIES:

Safety of raw materials:

    • Release safety certificate of raw materials for Development
    • Provide toxicological data of new raw materials
    • Management raw material data to support reg dossier (Safety parts, INCI)
    • Support Vigilance group, global customer service and project teams on safety and innovation support
    • Manage expertise for ingredients/products in terms of production issues
  • Leader to deliver Safety assessment of bulk/finished products and/or participate when contracted out and calculate safety margin of all ingredients per formula
  • Provide support for first assessment of a new cosmetic formula
  • Observe and give update of legislation changes regarding raw material and ingredients
  • Manage all outsourced activities within domain of expertise
  • Write safety section of dossier and defend product with Agencies as needed
  • Organize a Data base on safety ingredients for the unit
  • Establish KPIs and Track / monitors the performance to improve them further
  • Support all activities related to Safety in liaison with Claims Development and Product Development and provide necessary expertise and support decision globally in this field

YOUR PROFILE:

  • PhD master in toxicology /chemistry / pharmacy or equivalent with minimum 10 years’ experience in Safety assessment
  • Strong experience in cosmetics
  • Strong experience with safety and toxicology aspects.
  • Proof of safety assessor courses including certificates
  • Proven record of experience in safety assessments of ingredients and cosmetic products marked WW
  • Strong leadership skills
  • Excellent oral and written communication skills
  • Strong communication skills;
  • Expert level oral and written English

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Global Marketing Manager HCP-Skin Care

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 Marketing Manager with good experience with Healthcare products 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

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)

VP of Clinical Services Germany

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a VP of Clinical Services to join one of their office in Ulm Area, Germany and manage full service Clinical CRO division.

Responsibilities:

 

  • Responsible for all operational and strategic aspects of the design and implementation of clinical trial services, overall client satisfaction and divisional profitability
  • Supervise and develop 6 Departmental Heads to assure high quality Service delivery.
  • Leading, guiding and inspiring approx. 80 employees, through your Clinical Services
  • team (Clinical Conduct and Medical Services in our Phase I CPU, Clinical Laboratory,
  • Project Management, Data Management, Biostatistics, Medical Writing,
  • Regulatory Affairs and Monitoring Services)
  • Supervise ongoing projects and assure their performance with respect to quality
  • standards (SOPs, ICH-GCP), contract and timelines
  • Responsible for the divisional P&L, with oversight of the clinical program budget
  • across the portfolio
  • Providing active support and participation in client acquisition and contracting in
  • close collaboration with Business Development and the other divisional leaders.
  • Assure a continuous communication between the project team and client for an
  • effective study performance, respecting administrative and regulatory authority matters, ensuring client satisfaction
  • Further development and improvement of the divisional organization including
  • structure, processes and systems with the objective of process efficiency, quality
  • enhancement and margin optimization
  • Fostering an environment supporting innovation and smart risk-taking in Clinical
  • Services to help the division continuously evolve and improve.

 

Your profile:

 

  • PhD or equivalent in Life Sciences (medicine or healthcare discipline preferred)
  • 15+ years of experience in Clinical Development, particularly in Early Development,
  • preferably in both Pharma and CRO, with at least 10 years of project and/or line
  • management experience in a Clinical CRO
  • Knowledge and experience in planning, conducting and reporting of clinical trials,
  • including practical experiences in Project Management, Clinical Operations and at
  • least a solid understanding of Data Management, Biostatistics and Pharmacovigilance.
  • Experience of leading a large operational team and effecting change
  • Strong financial acumen with a solid understanding of proposal and contract generation, operational and margin growth and budget management
  • Proven track record of succeeded business growth
  • Leadership and hands-on management, influencing skills, high personal initiative
  • and team spirit, commitment, and accountability
  • Distinct organizational, problem-solving and analytical skills
  • Excellent English skills oral and written, and at least a basic understanding of German.

 

Please send your appliation to noliva@axepta.com 

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 :

 

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

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

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

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

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

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

Ø 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;

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

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

Ø Monitor vendor and CROs performance and ensure continuous oversight;

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

 

Your profile :

 

Ø University degree or equivalent in Life Sciences.

Ø Fluent in English – French is an asset

Ø Must have experience working in Oncology studies

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

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

Ø Experience in management of CROs, vendors and consultants.

Ø Strong project management skills.

Ø Excellent budgeting, planning, and communication skills.

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

Ø 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 :

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

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

Ø Support pour l’évaluation des risques

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

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

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

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

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

Ø Aider à la gestion des sous-traitants dans son scope

Ø Contribuer à mettre en place la culture d’Enterprise.

Ø Travailler en étroite collaboration avec les ingénieurs de production

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

 

Votre profil :

 

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

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

Ø Très bonne capacité de communication

Ø Très bonne connaissance du système qualité et des GMPs.

Ø Expérience avec les inspections des autorités de santé

Ø Français courant et anglais professionnel

Ø Capacité à prendre des décisions pragmatiques et orienté résultat

 

Responsable Qualité et Validation Biotech

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 :

 

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

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

Ø Support pour l’évaluation des risques

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

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

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

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

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

Ø Aider à la gestion des sous-traitants dans son scope

Ø Contribuer à mettre en place la culture d’Enterprise.

Ø Travailler en étroite collaboration avec les ingénieurs de production

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

 

Votre profil :

 

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

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

Ø Très bonne capacité de communication

Ø Très bonne connaissance du système qualité et des GMPs.

Ø Expérience avec les inspections des autorités de santé

Ø Français courant et anglais professionnel

Ø Capacité à prendre des décisions pragmatiques et orienté résultat