Life Science

Senior Healthcare Marketing Manager – English fluent

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 jean@axepta.com

Pharma – Regulatory Affairs RA 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 Fournièere at jean@axepta.com

Regulatory Affairs Submission Associate

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

Due to this growth my client is looking for a Regulatory Affairs Submission Associate with good experience in Electronic Document Management System.

In this challenging and dynamic role, you will support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products.

Regulatory Affairs Submission Associate

YOUR RESPONSIBILITIES:

  • Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
  • Lead timely receipt and dispatch of administrative documents and their legalization necessary for registration, renewal and variation files 
  • Be an ad-hoc support for European countries
  • Work closely with the regulatory team to lead new registrations and maintenance of the registered products.
  • Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update.

 

YOUR PROFILE:

  • BSc in Scientific or equivalent experience with an experience of minimum 1-2 years in regulatory affairs, ideally in global organization for international countries.
  • Experience in a multinational environment
  • Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database
  • Fluent in English, Spanish is a plus

Clinical Data Manager

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

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

Your Responsibilities :

 

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

– Be in contact with the global authorities.

– 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)

– Act as EDC representative

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

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

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

– 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.

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

 

Your Profile :

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

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

– Strong knowledge of CDISC standards is required ;

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

– Strong critical thinking and problem solving skills ;

– Able to rapidly adapt to changing environment and circumstances ;

– Fluent in English and French.

Head of Molecular Dermatology

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 Head of Molecular Dermatology whom will be responsible for the strategy, conduct and interpretation of the Global Molecular Dermatology activities (genomics, proteomics, metabolomics, morphology and molecular histology, bioinformatics and biological interpretation) and translational activities necessary for identification, design and progression in development of future systemic (oral, biological) and topical drug candidates.

 

Responsibilities:

 

  • Contributes to define the future strategic areas of Research
  • Contributes to implement the Research Strategy in line with the overall strategy and implement the corresponding technological solutions.
  • Contribute, in cooperation with other functions of Research to the definition of biomarker strategy necessary for the preclinical and clinical evaluation of the targets
  • Contributes to the definition and implementation for each program of the necessary translational activities.
  • Proposes the strategy in Molecular Dermatology and associated bioinformatics activities in line with the global strategy
  • Contributes to the evaluation and prioritization of projects.
  • Defines the needs, selects and maintains a pool of CRO partners to conduct the Molecular Dermatology and associated bioinformatics activities needed to implement the strategy.
  • Organizes and directs the activities of Molecular Dermatology and associated bioinformatics in the Research and Development phase, necessary to ensure the clinical evaluation of a portfolio of innovative projects aligned with the strategy
  • Organizes and directs the interaction with the CRO partners for all Molecular Dermatology, bioinformatics and biomarker activities.
  • Contributes to the definition of the innovation strategy in the field of biology and participates in the implementation of the selected strategies.
  • Contributes to the identification, selection and management of strategic collaborations of the Research Department
  • 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 maximizing the value proposition of Research and Development projects.

 

 

Your profile:

 

  • PhD in general biology or PhD in a discipline of molecular biology (genomics, proteomics, metabolomics …) or equivalent.
  • Post-doctorate in an academic or industrial environment – preferably abroad.
  • Academic training or acquired through the experience of pharmacokinetics and pharmacology in vitro and in vivo.
  • Academic or experiential training in the drug discovery and development process and in particular in the development of oral small molecules and biologics (monoclonal antibodies etc.)
  • You have minimum 15 years of expertise in academic or industrial research in the field of in vitro and in vivo pharmacology associated with human health, of which an important part in the field of molecular biology (omics).
  • You have excellent knowledge of bio-marker approaches in clinical research.
  • You have demonstrated a successful experience conducting collaborative research programs with external partners.
  • You have good knowledge of skin biology and dermatological pathologies, immunology and biology of inflammatory processes of inflammation.
  • You have excellent knowledge of 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 speak and write English fluently.

Please send application to noliva@axepta.com 

Clinical 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

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

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 car 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 Marine Dollat at mdollat@axepta.com

Senior Medical Expert Healthcare/OTC

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

Due to this growth my client is looking for a Senior Medical Expert with strong experience in OTC drug products to join their in Lausanne area.

Responsibilities :

  • Promote science based innovative projects and contribute to development and implementation of new scientific concept
  • Contribute to and support development of Cosmetics, Medical Devices OTC products
  • Deliver medical expertise as requested
  • Expert contribution in due diligence as needed
  • Responsible for the validation of the medical content of Idea Briefs
  • Accountable for medical/scientific relevance of claim support strategy
  • Contribute to the development of the clinical plan upon request and in case of complex and/or innovative projects
  • Contribute to and Support development of Medical Devices and OTC products
  • Accountable for providing effective CDP for OTC products and Medical Devices
  • Responsible for the clinical sections of regulatory documents
  • Review and contribute to dossier submission documents in collaboration with internal stake holders
  • Ensure that internal SOPs, processes are followed
  • Propose/implement any measures susceptible to improve clinical and innovation development processes and strategies
  • Responsible for providing internal training on skin conditions to the Clinical Operations Team and the overall healthcare team
  • Review and validate the medical content of internal publications
  • Contribute to Due Diligence evaluation and provide Medical Expertise as needed

 Profile :

  • Medical Doctor
  • 10 years minimum of experience of clinical development / research in pharmaceutical and/or cosmetic industry or CRO
  • Experience in Dermatology, development of OTC products mandatory. Medical Device Development knowledge is a plus
  • Strong communication skills; Expert level oral and written English
  • Results orientated with a hands-on, can-do attitude

Clinical Trial Associate (CTA)

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

 

Due to this growth my client is looking for an experienced CTA to join them in Lausanne area.

 

Responsabilities :

  • The Clinical Trial Associate (CTA) is involved in the set up and follow-up of the studies, in the management of study documentation and actively supports the Clinical Research Associate (CRA) and Clinical Project Managers by creating, updating, distributing study materials, tools and documents.
  • Generate, finalise and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CPM for meeting preparation.
  • Verify vendor’s work order and create / update purchase orders accordingly, with confirmation from CPM.
  • Ensure review of study budget under responsibility of the CPM.
  • In case of short / unexpected absences of the CPM, systematically act as Backup and primary point of contact of the study by directing the action items to the most appropriate person.
  • Contribute to the quality of all activities and key steps of the clinical study deliverables, and the delivery of the clinical study according to the ICH GCP and local applicable regulations, and in accordance with SOPs.
  • Update and/or track study reporting tools

 

Your Profile :

 

  • University/College degree level or equivalent in a relevant discipline.
  • Proven track record of at least 2 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology.
  • Experience in Management and filing of Trial Master File content
  • Excellent spoken and written English
  • Customer orientation and Team spirit, with ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization;
  • Ability to communicate with cross-functional teams.
  • Strong organizational skills with ability to manage stress, pressure and deadlines.
  • Good to advanced computer skills with requirement of MS applications.

Please send your CV to noliva@axepta.com

Associate Director Global Regulatory Affairs Oncology

My client is a growing international biopharmaceutical company based in the French part of Switzerland with ongoing growth.

Due to this growth, my client is looking for an Associate Director Global Regulatory Affairs with strong experience working at global level and Oncology.

Responsibilities:

 

  • Supports regulatory objectives, advice and strategy in alignment with department and corporate goals
  • Works with multi-functional teams to ensure that regulatory requirements for the assigned products are achieved.
  • Be the official liaison with European Regulatory Agencies and will support preparation and conduct of meetings with European Regulatory Agencies
  • Plans and manages regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs.
  • Responsible for ensuring that the company is developing and executing optimal regulatory strategies for Europe and International geographies, and for preparing and supporting interactions with regulatory authorities appropriately
  • Develop and lead globally aligned regulatory strategies for novel small molecule and biologics.
  • Activities include Scientific Advice, Orphan Drug Designations, paediatric plans, registration procedures to optimize successful regulatory review and approval
  • Review and interpret regulatory correspondences for global project teams
  • Provide regulatory support to inter-departmental project teams and interact proactively with other functions, contract research organizations, partner companies, and health authorities
  • Work with global regulatory team to agree contents for timely submissions to Health Authorities
  • Plan and lead the preparation, review, and approval of compliant regulatory documents for European and International CTA and MAA submissions throughout the product lifecycle
  • Coordinate the preparation of responses to questions and inquiries from Health Authorities.
  • Prepare and submit CTA amendments, DSUR and MA Renewal in accordance with regulatory submission schedules and regulations.
  • Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format
  • Coordinate and support regulatory activities with affiliates and consultants including regulatory review of promotional materials by specific country RA affiliate/consultant
  • Contribute to improvements in department operating procedures

 

 

Your profile:

  • BS degree, preferably in a scientific discipline with a minimum of 8 years pharmaceutical / biotechnology experience and with a minimum of 5 years regulatory experience, preferably including one full submission or line extension through authorization
  • Experience in interactions with regulatory agencies.
  • Experience with clinical trial applications
  • Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability
  • Experience in oncology and orphan products

Please send your CV to noliva@axepta.com

Experienced CRA

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

 

Due to this growth my client is looking for an experienced CRA to join them in Lausanne area.

 

Responsibilities:

•Oversees clinical trial set up including site selection and set-up.
•Coordinates the overall interaction with clinical study sites and monitors CROs/site activities.
•Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.
•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.
•Identifies and qualifies clinical sites to ensure quality investigative sites.
•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.
•Establish country and/or site-specific recruitment targets with internal / External CRAs and CPM to meet timelines.
•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.

Your profile:

•University degree, preferably in life sciences or equivalent qualification.
•Minimum of 3 years progressive relevant clinical experience in clinical operations as Clinical Research Associate with Pharma/Biotech and/or CRO.
•Good knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
•Good knowledge of relevant local regulations.
•Basic understanding of the drug development process.
•Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
•Fluent in English

Please send your CV to noliva@axepta.com

Senior Regulatory Affairs Specialist

My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.

Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a strong FDA experience to join them in Geneva area.

This position will report to the Regulatory Affairs Head.

YOUR RESPONSIBILITIES:

  • This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:

– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)

– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions

– Assist the team in the Regulatory evaluation of US changes (Change control)

– Manage the maintenance of registration dossiers (modifications and renewals)

  • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
  • Prepare and support audits conducted by Notified Bodies and Competent Authorities
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributeurs
  • Follow-up the regulatory monitoring for medical devices

YOUR PROFILE :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
  • Be familiar with US FDA regulations
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Excellent knowledge of English language
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment
  • A first experience in project management would be a plus

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

Senior Clinical Data Manager

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 Clinical Data Manager with strong Oncology experience to join them in Lausanne area.

 

Your main responsibilities:

  • Define and manage Clinical Data Management timelines on multiple studies or programs
  • Coordinate/perform CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review and query generation and data coding.
  • Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs

Your profile:

  • Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
  • Experience of 6 years minimum in clinical data management, with strong experience using major EDC systems
  • Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements
  • Fluent in English, good knowledge of French an asset

Seniro Healthcare Professionals 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

Please send your CV to noliva@axepta.com 

Global Consumer Engagement Head

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Consumer Care strategic group based in Lausanne area.

 

Due to this growth of activities my client is looking for a Global Head of Consumer Engagement & Digital

 

Responsibilities:

 

Drive a consumer centricity mind-set throughout the whole consumer care business by:

·         leading the consumer engagement strategy at a global level for the Consumer Care Strategic brands.

·         driving and nurturing the relationship with agency partners that provide consumer engagement services

·         leading consumer engagement best practice & synergies across franchises and key markets, with focus on digital / social media.

·         mentoring and coaching the global marketing team and key market teams in use and delivery of engagement programs on a day-to-day basis as well as through the delivery of trainings programs, webinars and external speaker’s sessions.

·         Deliver the consumer engagement roadmap

·         Contribute to the development of consumer centric campaign Ideas / executions for the priority brands

·         Accountable for and co-Lead with marketing consumer engagement strategies and create attractive and rewarding brand experiences. This includes delivery of consumer communication channel and marketing investment guidelines and modular global toolkits / content to be leveraged locally

·         Works in partnership with communication agencies to ensure all brand communication contributes to positively enhancing consumer engagement into the brand

·         Identify opportunities for synergies across franchises and lead best practices deployment to help support execution in key markets

·         Contribute to the Development and updates of consumer portrait, consumer engagement funnel for the brands and other brand building initiatives with a view to activate the Brand Equity Model

·         Establish KPIs and Track / monitor the performance and health of these assets to improve them further and inform back the global strategy.

·         Closely collaborate with agency partners (eg. google, FB, Hogarth) to leverage necessary support (eg. foundational, analytics, and consumer engagement solutions critical for digital programs)

 

 

Your profile

 

·         Master degree or equivalence in communication / marketing

·         Minimum 7-10 years’ experience in Consumer engagement programs with specific focus on Digital in the FMCG industry and in a matrix organization at a global / regional level

·         Solid brand marketing as well as direct report management experience (3-5 years)

·         Thought leader in consumer communication channel and brand marketing investment strategies

·         Proven track record of turning analytics, consumer and market trends into strategies and initiatives to feed brand growth and equity

·         In depth experience in delivering complex consumer engagement projects, possessing a Strategic vision on building consumer engagement in brands

·         Strong communication skills, proficiency in English, any other language is an asset

Please send your CV to noliva@axepta.com

Global Strategic Marketing Manager Oncology

My client is an innovating, dynamic and niche international biopharma company currently expanding their business development and commercial department.

Due to this growth my client is looking for a Global Marketing Strategic Manager with strong Oncology experience and pre-launch to join them in Lausanne area.

Responsibilities:

 

  • Responsible for building and integrating the Marketing strategy of oncology products into the company’s portfolio development plan in accordance with the company objectives.
  • Gather and analyse market insights covering key global markets.
  • Key contributor to the creation of market-driven products & disease area strategies, creating and refining target out-licensing profiles
  • Liaise with the communication team to identify communication needs and channels, creating opportunities to develop product awareness within target audiences
  • Support the licensing team with assessment of business opportunity for new products with Market Intelligence team
  • Build and implement advocacy plans in collaboration with Medical team
  • Optimize Target Product Profile (TPP) development, with clearly differentiated competitive advantage and value proposition ensuring consistency with TOP
  • Establish strong and productive relationship with key stakeholders and other team members
  • Work closely with agencies and Clinical Operations to speed up enrolment, increase visibility, and secure optimal enrolment and retention of on-going trials, designing and implementing recruitment campaigns to engage both investigators and patients.

 

Your profile:

  • Bachelor’s degree, in scientific or business discipline
  • Minimum 7-8 years experience in marketing in a large or mid-sized pharmaceutical company
  • In-line brand marketing experience in Oncology
  • Broad commercial experience including pre-launch
  • International experience, including US and Europe
  • Experience in leading and motivating agency partners to deliver high impact marketing and market shaping initiatives
  • Experience and knowledge of a broad base of external customers including patients, prescribers, payers, providers
  • Thorough understanding of product positioning, product plan and brand development processes and necessary commercial touch points

 Please send your CVs to noliva@axepta.com 

Biossample Coordinator

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

Due to this growth my client is looking for a Biosample Coordinator join them in Lausanne area to manage the operations and logistics necessary to execute the testing, analysis, and storage of biological samples for clinical trials and translational projects in compliance with relevant regulations.

 

Responsibilities:

 

  • Work in matrix organization in close collaboration with the Clinical Operations team and Translational Medicine functions to manage sample tracking, receiving, and storage processes for clinical and translational projects.
  • Support clinical study activities in the preparation and review of study-related documents (such as ICF, CRF, laboratory manual, DTS, etc.).
  • Interface with laboratory personnel, sample processing vendors, and other vendors as needed to ensure proper shipment of samples, respond to issues as needed, and to ensure study objectives are met.
  • May contribute to the assessment of site and lab feasibility for biological sample collection, handling and storage.
  • Be responsible for the development and maintenance of a biorepository database for human and non-human biological samples.
  • Ensure biosample process consistency across clinical studies within their respective projects and manage sample logistics from patient to data, in compliance with GXPs.
  • Participates in process improvement projects (SOPs, work instructions, training materials) in collaboration with QA and clinical study teams.
  • Forecasts the biosample operational costs and review contracts and invoices.

 

Your profile:

  • Degree in life sciences
  • Strong knowledge and good understanding of clinical trials and translational medicine in biomedical research.
  • Minimum of 3 years proven experience working in teams managing clinical studies.
  • Proven experience working with clinical biosample logistics and operations.
  • Knowledge of GCP, GCLP and ICH guidelines, and animal welfare regulations (training can be done after recruitment).
  • Excellent IT and analytical skills. Experience with sample management systems and procedures is a plus.
  • Fluent in English

Please send your application to noliva@axepta.com

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