Kategorie: Gesundheit - Medizin - Pflege

Our client is a well-established non-profit drug research and development organisation who partners with private industry, public institutions, academia and NGOs to advance new treatments in disease-endemic countries. For their office in Geneva, we are looking for a *Senior Medical Consultant* for a *7-month contract*. * Main Responsibilities:* * Supporting the project scientific quality and review processes with the R&D Director and supporting the careful review of documents presented to the Scientific Internal Review Committee and Scientific Advisory Committee (SAC) for all programmes. * Participates in the review of the disease strategies as a member of the Scientific Internal Review Committee and participates to the SAC meetings * The SMC is accountable for reviewing and proposing green light to the R&D Director, to the share with SAC the Protocol Synopsis. S/he is accountable for advising on the final approval of protocol synopsis and supporting the R&D Director to ensure SAC comments are incorporated in the final synopsis. * Supervises the Clinical Quality function who guide the clinical teams to prepare and put in place the requirements for inspection readiness. * Reviews reports of critical major quality issues, suspected and serious breaches of misconduct, and jointly with the Initiative Director brings it to the attention of the R&D Director * Supporting the safety risk management process and development of safety risk management template, and supporting the availability of RMP for selected projects * Reviewing patient safety risk, including ensuring that clinical safety reporting meets all requirements and expectations (supporting putting in place safety risk management plans appropriate to the development phase of the project, SAE reporting, pharmacovigilance for approved products (as appropriate), provision of annual and other safety reports, etc.). * Includes the management of any serious incidents associated with any clinical activity including the escalation and communication process and convening an appropriate senior management committee to oversee and manage the process. * Qualifications and Experience:* * *Relevant working/residency permit or Swiss/EU-Citizenship required;* * Medical Degree * At least 15 years' experience in clinical research in a Pharmaceutical or Biotech company * Sound experience in Clinical Development, Quality and Pharmacovigilance * Fluent in written and spoken English.

*About You* We are looking for a Medical Affairs Manager at our site in Fribourg, Villars-sur-Glâne. In this role you will be directly reporting to the Medical Affairs Team Lead and are responsible for the independent scientific support of products in the field of nephrology and of the various departments in the Rx area. Your tasks as subject-matter expert include, but are not limited to: * Answering medico-scientific inquiries (internal and external) * Medico-scientific support for marketing in the preparation of promotional materials * Strategic contribution to the brand team in close cooperation with the marketing and sales departments * Scientific training for field staff * Review and evaluation of relevant scientific literature * Planning, implementation and support of current and new projects such as clinical studies, market access initiatives and registries * Scientific engagement with key experts and the physician community in the field * Maintain a strong working relationship with Company Headquarters * Organisation of seminars, training events, symposia and advisory boards - face-to-face or in the virtual setting * Teaching of scientific topics to Sales, Marketing and other Medical collaborators For this exciting position, we are looking for an entrepreneurial person who wants to prove their analytical and conceptual skills on a daily basis. You are a reliable person and have an independent way of working. Additionally you bring the following profile: * A successfully completed Master or doctoral degree in medicine, pharmacy, pharmacology or other natural sciences (preference for PhD or MD) * Experience in the healthcare or pharmaceutical industry (e.g. patient experience or Medical Affairs skills) * Fluency in English and German is a must, both orally and in written * Good knowledge in French * Willingness to travel throughout Switzerland and occasionally abroad; at ease with digital formats of customer interactions You complement our team optimally if you love challenges, have a self-starting attitude, enjoy engaging with people and are highly committed. As a person with good communication skills, you also appreciate contributing your strong scientific knowledge on a daily basis and acting as an interface between Vifor Pharma and its customers. *About Us* Vifor Pharma Group is a global pharmaceuticals company. It holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH).

Our client, a dynamic bio-pharmaceutical company headquartered in Switzerland and covering multiple therapeutic areas, is looking for a *Senior Clinical Data Manager *for a *permanent* role based in the *French Speaking area of Switzerland*. As an ideal candidate you will have at least 5 years of experience in Clinical data management with strong experience in major EDC systems and oncology studies. *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; * Ensure appropriate study specific training is provided to assigned study teams and documented; * Ensure ongoing and timely data capture and data cleaning, including external data sources; * Provide/coordinate data management support to study teams to support timely and ongoing data review and monitoring; * Ensure study timelines are met and data quality is according to high industry standards; * Lock, transfer and archive databases; * Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs. * Qualifications and Experience:* * *Relevant working/residency permit or Swiss/EU-Citizenship required. * * Scientific or technical education background, ideally university level; * Experience of 5 years minimum in clinical data management, with strong experience using major EDC systems and related tools and technologies; * Experience of overseeing the set-up, maintenance, control, cleaning and validation of clinical study databases; * Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements; * Oncology experience is strongly desirable; * Good planning, organizational and communications skills; * Ability to effectively work and collaborate in a complex matrix organisation; * Fluent in English, good knowledge of French an asset.

Our client is an innovative mid-size Pharmaceutical company with global headquarters in the German speaking part of Switzerland. A well-funded and stable organisation, our client enjoys the backing of a number of leading, globally recognized institutions. They currently market 3 leading products in anti-infectives and oncology via a global alliances and extensive partner network. We have a long standing relationship with this company and have placed a number of key people in the organisation in the past, all of whom have given us some great feedback from their time working there. * Main Responsibilities:* * Responsible to manage contract research organizations (CROs) performing data management and statistical tasks for clinical studies; * To ensure that the deliverables are provided on time, to a high level of quality and adhering to companys requirements and to support clinical review of study data in SAS; * Lead study team review of Data Management and Statistics deliverables; * Actively manage studies performed by CROs for Data Management and Statistics (contracts, payments, timelines, quality, cost and deliverables); * Review and approve Data Management and Statistics study deliverables provided by the CRO (eCRF/database set-up, data management plan, statistical analysis plan, datasets (CDISC), tables, figures and listings) in order to ensure compliance with the study protocol and company standards; * Provide regular feedback to study team on study progress and activities at the Data Management and Statistics CRO; * Regular review of study data with clinical team. Support clinical review of data in SAS; * Lead database lock plans and activities. * Qualifications and Experience:* * *Relevant working/residency permit or Swiss/EU-Citizenship required;* * Master Degree in Life Sciences, computational sciences; * At least 5 years' experience as a lead data manager; * Significant experience with EDC systems such as Rave or Inform; * Project management; * Oncology experience; * Programming experience. Hands on for SDTM review, data cleaning/review, UAT. * Knowledge of CDISC standards; * High organizational, analytical and administrative abilities.

A fantastic opportunity has arisen for a Global Medical Lead to join one of the most exciting and fastest-growing pharmaceutical companies in the world. This unique role based in Switzerland sits within the Global Medical Affairs Division. This new expansion of the medical affairs division empowers you to work with total autonomy with a high level of entrepreneurial spirit and mindset. You will have full accountability to create, implement and execute the global medical affairs strategy and deal with important registrations and launches which are forthcoming, along with driving the vision and success of the medical affairs department. The current global team is staffed with individuals with high scientific integrity and curiosity, this organisation has a very credible reputation for being one of the best employers in the pharmaceutical arena and a solid investment into research, innovation and long-term strategy. *You will be responsible for:* * Supply medical expertise through strategic planning and coordination of Global clinical studies * Serve as the scientific expert for external/ internal events, customers and stakeholders * Nurturing and maintaining a network of KOL's * Medical input into clinical development * Input into Global Med. Affairs Strategy, i.e. Scientific Platform, Publication Plan * Deliver strategic medical input and plan for Global lifecycle management * Development & execution of the Global TA Plan, TA Operational Plan, TA Medical Affairs Plan *You will bring to the role:* * A Medical Degree * Significant experience throughout the reg cycle, clinical development and launch process * 5+ years of Medical Affairs expertise * Significant rare disease, speciality products or Orphan drugs experience * International exposure (EMEA, Global, Europe, US) *In return you will receive: * * The opportunity to support pre-launch and early access strategy for associated drugs * Excellent Salary * Benefits package * Long term incentive and development * Full relocation support If you have the skills and experience for this opportunity and the ambition to take on this position, please call or email your CV today. Contact Reuben Riisager on + alternately you can email [](mailto:) - EARLY APPLICATIONS HIGHLY RECOMMENDED This job advertisement is placed by Haybury AG, Teichgässlein 9. 4058 Basel, Switzerland. All preselected applications will be forwarded to Haybury AG and be processed by Haybury AG according to Swiss law.

Senior Medical Manager - Liver Diseases Switzerland - Zug Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Making an impact on a global scale Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible Gilead Sciences was founded over 30 years ago and it is an ambitious, innovative, research-based biopharmaceutical company with a pioneering mind-set that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer, inflammation, invasive fungal infection and serious respiratory and cardiovascular conditions. The Swiss office is based in Steinhausen near Zug. In the liver disease therapeutic area ,Gilead Sciences is committed to elimination of viral hepatitis which is now entering a new phase, where the challenge lies in how to link the patients to care. We are currently looking to recruit a Senior Medical Manager to provide support to the Liver Disease therapeutic area. The role will report directly to Director, Medical Affairs and will predominantly be office based, although there will be approximately 40% travel both nationally and internationally. Responsibilities: Works collaboratively with Gilead personnel in Sales, Marketing, Market Access, Public Affairs, Pharmacovigilance, Clinical Research and global/regional Medical Affairs Team. Develops national strategic plan in line with global strategic planning. Implement medical strategy and tactics in collaboration with cross-functional team. Medical education on relevant therapeutic areas and medicine. Collects and analyses scientific data, publications and guidelines. Is responsible for medical content of Gilead organized medical education events and activities. Conducts disease awareness including treatment guidelines with patient advocates, community groups, medical providers, and patients. Is responsible for establishing and maintaining appropriate scientific relations with KOLs. This is an office based position, however candidate should have ability to travel approx. 40% within Switzerland and internationally- i.e. networking, visiting customers/KOLs, attending conferences which will include occasional weekend travel. Represents the company to various groups of experts, medical professional groups, scientific societies, regulatory and payer groups at local and international scientific meetings. Organizes and participates at advisory boards and key conference activities. Supports the development of local clinical data through clinical trials and investigator studies. Analyses trial data and provides interpretation to marketing and sales departments. Ensures appropriate medical quality of promotional materials and activities within approval process. Answers and responds to medical inquiries to customers. Supports Drug Safety Dpt. providing medical expertise in the analysis and review of adverse events Essential Knowledge/Skills: Degree in Medicine, Pharmacy or Bioscience. Preferred (but not essential) medical expertise in the area of hepatology or gastroenterology. Fluent in English and German. Built network and long term relationships with the key thought leaders and other relevant health care professionals. Ability of transferring complex scientific/medical data to understandable medical communication and education. Excellent communication, presentation and negotiation skills are required along with the ability to provide clear and concise analysis of quantitative and qualitative concepts. Ability and wish to continuously learn and improve and to work as a member of several local and international cross functional teams. Able to work with a high level of autonomy and independence. Sufficient understanding of Clinical Research area in order to provide support for the link between company R&D and investigators. Excellent analytical skills, demonstrated by the ability to identify and understand issues and problems, and interpret data in a manner that provides appropriate recommendations to respective cross functional groups. Ability to utilize complex scientific resources for presentations in a variety of different settings. Excellent verbal, written and interpersonal communication skills. Driving license. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. To apply, visit Copyright ©2017 Jobelephant.com Inc. All rights reserved. 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Senior Manager, Market Access I am now partnered with a rapidly growing, global pharmaceutical company who are looking to grow with a Senior Manager of Market Access to become a leading member of the Market Access team and be responsible for leading and submitting P&R dossiers on a global scale. Responsibilities -Establish a clear pricing policy with appropriate governance -Leading projects while submitting P&R dossiers on a global scale -Maintain and update all relevant P&R tools -Lead all global and local pricing decisions Required Experience -Educated to degree level (ideally masters) -Fluent in German/English (desired) -Experienced in reimbursement dossier compilation -Travel is 20% of this role To find out more about this exciting opportunity, get in touch today! Christian Lee T - 236810 E - Apply now

CK Clinical are recruiting for a Senior Director, Global Medical Affairs (Cell Therapy) to join a small speciality pharmaceutical company based in Geneva, Switzerland on a permanent basis. This role could also be based in Hertfordshire, UK or Amsterdam, Netherlands. *Senior Director, Global Medical Affairs (Cell Therapy) Role:* The main purpose of the role will be to lead the strategy and preparation of global launch of a cell therapy in the ophthalmology area. As well as a play a pivotal role in the establishment of a new centre of excellence for cell therapies for the company. *Key responsibilities include to:* * Direct the development and execution of comprehensive global Medical affairs Strategy and activity plans and programs such as pre-launch, launch and post-approval plans and Life cycle Management to show cell therapy assets value. * Lead brand medical strategy development and execution consisting of evidence data gap analysis, data generation to fill those gaps, data analysis and interpretation, publications, medical communication, medical training, medical information and congress strategy. * Lead the engagement with external key stakeholders in the region (e.g. KOL, Health Care Practitioners, Health Authorities, etc.) ensuring coordination with countries and other internal functions. * Be accountable for planning and executing global advisory board meetings and assure communication of key findings and insights across the organization (clinical development, medical affairs and commercial teams). * Establish, maintain and direct interactions with key opinion leaders relevant to assigned therapeutic area and cell therapy platform. Accountable for development & execution of global KOL engagement plan. *Your Background:* * Medical Doctor (Essential) with PhD or MBA (Desirable). * Minimum of 8 years medical affairs leadership experience. * Experience in launching products on a global and/or regional basis. * Advanced therapy (cell or gene therapy) or rare disease experience. * 'Hands on' leader with excellent communication skills. * Solid understanding of EU, Asia and US regulatory framework. It is essential that applicants hold entitlement to work in the country where the services will be delivered. CLINGEN