Author: Noemie Oliva

Global Medical/Scientific Communications Manager

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 Global Medical Communications/Scientific Communications Manager to join their growing Global Medical Affairs team.

Responsibilities:

  • Creation of Global Scientific Content, the provision of Global Medical Information as well as Global Medical Training services ensuring the timely and high-quality delivery of medical, scientific and technical information and data
  • Management of medical communication operations, such as development of electronic document repositories or global standard operating procedures (SOPs).
  • Ensuring high quality and expediency in the development and distribution of medical, scientific and technical information to both internal and external customers
  • Maintaining a high level of technical and scientific expertise through familiarity with medical and scientific literature on the Incyte pipeline asset
  • Contributing to the global medical strategy and ensuring execution of global medical communications activities in accordance with the departmental operational model and expectations while meeting appropriate legal, regulatory and corporate requirements
  • Engaging with other functions in developing, modifying and executing departmental and company procedures and policies that have immediate operational effect
  • Planning, developing and maintaining key medical information documentation, this includes but is not limited to Medical Information Response Letters, Questions & Answers documents, medical slide decks
  • Supporting the Global Medical Information Call Center through training, monitoring inquiries, and managing escalated inquiries ensuring prompt, accurate, quality-assured responses to medical/ scientific/ technical information requests from healthcare professionals, patients, caregivers, and the general public
  • Participating in international medical & scientific congress activities, and developing congress materials (e.g. brochures, videos)
  • Developing training modules primarily for medical teams but also for the rest of the R&D organization.
  • Supporting the Medical Communications needs of regional and local affiliates and ensuring consistency of medical messaging across the globe by creating and maintaining effective communication channels, facilitating training, and providing access to key scientific documents.
  • Participating in development and maintenance of standard operating procedures (SOPs) for Global Medical Content Creation and Review, as well as Global Medical Information Services

 

Your profile:

 

  • Advanced degree in Life Sciences (e.g., Ph.D.) or Pharmacy sciences (e.g., Pharm.D.), or equivalent is required
  • Minimum 3-5 years’ experience in the field of Scientific Content, Medical Information and/or Communications is a must
  • Experience in medical scientific exchange (e.g., MSL slide decks) material management and execution at a global level
  • In-depth understanding of legal requirements, regulatory issues, codes of practice and guidelines as relevant to the provision of Medical Information and medical data communication and scientific exchange
  • Must be fluent in English, other languages is an asset

Please send your CV to noliva@axepta.com 

 

 

 

Senior Analytical Scientist Oral and Topical Form

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

 

Due to this growth my client is looking for a Senior Analytical Scientist with experience working on Oral and Topical forms.

 

Responsibilities:

 

  • Contribute to design and oversee Small Molecule, oral and topical, analytical development plan and stability programs, any applicable regulatory requirements.
  • Contribute to design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site.
  • Outsourcing of key activities such as drug substance characterization, method development/optimization/validation/transfer, proposing specification and analytical control strategies, recommending stability programs.
  • Design stability program in close cooperation with Internal Experts and external partners
  • Contribute to analytical development plan and stability program for primarily Drug Substance and possibly Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework
  • Solve complex problems (e.g. deviations, OOS) through collaborations with others
  • Review, author and approve key documents such as method development reports, validation protocols/reports, and justification of specifications, stability protocols/reports and relevant sections of regulatory filings (DMF, IND, IMPD, NDA etc.)
  • Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder
  • Ensure close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements and report in a timely manner any major or critical issue
  • Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition

 

Your profile:

  • PhD with 5 years of working experience or MS with 15 years of working experience in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or closely related to the field
  • Strong track record of success with oral and topical developments
  • Experience working with external partners (e.g. CDMO, CRO, Academic)
  • In-depth scientific knowledge and experience in developing and validating analytical methods, covering different technics and methods (e.g. microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques
  • Solid understanding of characterization, technology transfer and troubleshooting when it comes to drug substances (Oral and Topical)
  • Fluency in English, both spoken and written, any other language an asset

Please send your profile to noliva@axepta.com 

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 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

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 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 

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

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 

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  

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

 

 

 

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 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

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%

Senior Expert Scientist Toxicology

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

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

Activities and Responsabilties :

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

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

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

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

       Participates in project evaluation and prioritization activities

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

       Contributes to the management of the global research budget

       Contributes to the execution of strategic collaborations of the Research Department

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

 

Expected qualifications :

       PhD in Toxicology (ERT or DABT).

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

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

       Specialization in pharmacology, immunology or pharmacokinetics

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

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

       You have a proven track record of Multidisciplinary Team Leadership.

       You have a good knowledge of pharmacokinetics and early clinical development

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

       You speak and write English fluently.

Senior Medical Lead-Immuno-Inflammation

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

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

Responsabilities :

 

Ø Lead the medical communication plan aligned with global strategy

Ø Publication plan

Ø Scientific material production plan

Ø Medical training plan

Ø Scientific event (ad-boards and congresses) plan

Ø External expert engagement plan

Ø Scientific society engagement plan

Ø Patient organization engagement plan

Ø Promotional material review plan

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

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

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

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

 

Your profile :

 

Ø Medical Degree required, Dermatologist would be a plus

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

Ø Fluent in English, written and oral