At the end of the webinar participants will have a better understanding of:
• What is company and medical affairs lead education and how it is perceived by audience
• What are the different perspectives existing among regulators, Pharma and agencies
• The potential for disease state medical education by medical affairs
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By João D. Dias1, Cesar Sanz Rodriguez2, Raphael T.B. Tan3
1 Medical Affairs & Clinical Development, Haemonetics S.A., Switzerland, Medical Affairs Professional Society (MAPS) MedTech Focus Area Working Group (FAWG) EMEA Co-Lead
2 Medical Affairs, MSD International GmbH, Switzerland, MAPS MedTech FAWG EMEA Co-Lead
3 International Medical Executive Consultants (IMEC), The Netherlands, MAPS MedTech FAWG member
This article provides an overview of the new MedTech European regulatory environment and opportunities for the Medical Affairs function to evolve and bring value to the respective organizations. The European Regulations ask for an increased effort from manufacturers to generate and communicate clinical evidence on the safety and performance of their Medical devices, In vitro-diagnostics and Drug Device Combinations. In conjunction with increased quality standards they make a compelling case for Medical & Scientific Governance with a prominent role for Medical Affairs in many pre- and post-market processes. A transformation of Medical Affairs into a strategic business function makes the medical device industry an exciting place to be for Medical Affairs professionals.
For over two decades, Medical devices and In-vitro Diagnostics have been regulated in Europe by Directives for MEDICAL DEVICES (MDD) and IN VITRO DIAGNOSTICS (IVDD)1,2,3 that were published in 1993 and 1998 respectively. A separate Directive for Active Implantable Medical Devices (AIMD) was published in 1990 with a last revision in 2009. According to these Directives, devices are approved for the European Single Market only after having obtained CE Mark for which manufacturers need to demonstrate conformity to essential requirements relating to the device’s performance and safety for patients and users. After public consultation by the European Commission in 2008 it became clear that an update of the Directives was needed, one reason being the simple fact that new technologies such as companion diagnostic devices were not yet covered. The need for revision gained traction after incidents with breast implants, transvaginal meshes around 2009 and metal-on-metal hip prostheses a couple of years later. Eventually, the revision process that started in 2012 resulted in the Medical Device Regulation (MDR) in which MDD and AIMD were combined and the In Vitro Diagnostics Regulation (IVDR)4,5. The new Regulations were published in 2017, with May 25, 2017 as the official date of entering into force. A transition period to full implementation of the MDR and IVDR was allowed for three and five years respectively, which means the MDR applies from May 26, 2020 and IVDR from May 26, 2022.
So far so good… and then the COVID-19 crisis struck Europe, right at the moment when the medical device industry and notified bodies are transitioning to the new Regulations. Therefore, in order to “take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus,” the European Commission has decided to move back the date on which the new MDR would fully apply by one year, to 26 May 2021. MedTech Europe, the European trade organization of medical device manufacturers, has advocated for a similar delay for the IVDR.
Since the early days of the global COVID-19 crisis the medical industry has made a so far unseen effort in finding (bio-)pharmaceutical solutions, developing vaccines and reliable test kits. Simultaneously, in an attempt to address the relative shortage of masks and intensive care equipment such as ventilators, traditional medical device manufacturers ramped up production. Although regulators accommodate the surge of new devices by fast tracks and exemption rules, new devices are subject to meticulous assessments of performance and safety. And rightly so, since national policies to curb transmission of the virus rely on the quality of diagnostics and personal protection equipment. Especially important is the scrutiny in assessing new medical devices which are intended to be used in the management of the most vulnerable and severely ill COVID-19 patients who end up in hospitals and ICUs.
In general the new Regulations devices, improve traceability and transparency and define stricter requirements to clinical evidence and post-market surveillance. The MDR now also regulates devices for cosmetic purposes such as colored contact lenses and cosmetic implant devices. The introduction of Unique Device Identification should improve traceability, and transparency is created by the European Databank of Medical Devices (EUDAMED) where all mandatory regulatory documentation on each device is kept and updated. Manufacturers must re-certify devices in accordance with the new regulations and update their technical documentation accordingly with special attention to higher clinical requirements for class III and implantable devices. A shift of focus from a mere pre-market perspective towards a life-cycle approach also includes stricter requirements regarding post-market surveillance, post-market clinical follow-up and vigilance.
This brings us to the Clinical Evaluation, which lies at the basis of CE mark approval and the life-cycle approach. It is defined as “a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety performance, clinical benefits of the device when used as intended by the manufacturer.” The Clinical Evaluation process is described in a MEDDEV (MEDical DEVices) guidance document. MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Although these MEDDEVs are not legally binding, it is expected that their guidance be followed, ensuring the uniform application of the various elements of the directives/regulations. MEDDEV 2.7/1 rev. 46 is the guidance document with regards to Clinical Evaluation and is prescriptive on the process, the required qualification of the evaluators and the contents of a Clinical Evaluation Report (CER).
The CER should “describe the intended clinical benefit and provide evidence of safety and performance” where performance is defined as “the ability of a device to achieve its intended purpose as stated by the manufacturer.” This report describes the risk profile of the device based on the technical documentation and provides an appraisal of all available clinical data related to safety and performance. Any evidence gaps and residual risk need to be addressed in Post-Market Clinical Follow Up (PMCF) studies to demonstrate long-term performance safety. The results from the intensified surveillance are laid down in the Periodic Safety Update Report (PSUR, mandatory for Class IIa/b and III) and Summary of Safety and Clinical Performance (SSCP, for implantables and Class III). These documents must be uploaded in EUDAMED, which allows public access to the SSCP.
Although European market approval of new devices can still be obtained by referring to clinical data of predicate equivalent devices, the MDR explicitly lists criteria by which equivalence can be claimed from a technical, biological and clinical perspective. The equivalence under the MDD was less well defined. Under the MDR, the predicate device must have a similar design, use the same materials and come in contact with the same tissues and body fluids, and be used for the same clinical indications. If a device does not meet these criteria, manufacturers need to generate their own clinical evidence with appropriate clinical investigations.
CE Marking requires Notified Body involvement for most medical device classes and is related to implementation of a Quality Management System, which must include plans pertaining to Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF). For non-sterile Class I devices, manufacturers can conduct the conformity assessment themselves and basically self-certify. For Class I devices that are sterile, measuring or reusable surgical instruments as well as for all higher device classes, oversight of a Notified Body is required. In the end, it is the Notified Body that issues a CE Marking Certificate and ISO 13485 Certification. Only with these certificates in place the manufacturer can prepare a Declaration of Conformity and put the CE Mark sign on their products and labelling.
In Vitro diagnostics (IVDs) are medical devices with which tests are performed using human specimens such as urine or blood. Familiar examples of such devices are pregnancy tests and tests for determining the level of glucose or cholesterol in the blood. The current directives distinguish between medium risk and high-risk lists of IVDs. Those IVDs not captured in these lists are automatically classified as low risk. Obviously more stringent market authorization procedures with Notified Body oversight apply to high risk IVDs. Whereas in the past only a minority of IVDs required involvement of a Notified Body, under the new classification an estimated 90% will now require it. The IVDD had some gaps and this binary system was thought to be no longer sufficient. Hence, like for the MDR, a risk-based approach classification was introduced based on the severity of the disorder tested for and possible consequences of an incorrect test result. Instead of two lists, the new IVDR now distinguishes four categories, Class A (lowest risk), Class B, Class C, and Class D (highest risk) and dictates that Class B and above IVDs will require oversight from a Notified Body as part of their conformity assessment.
Aside from the risk-based classification, it will not surprise you that the new IVDR has more features in common with the MDR. As is the case for medical devices, the IVDR requires clinical evidence and post-market performance follow-up. This will require a Performance Evaluation plan and report for all IVD Classes, which will describe how to demonstrate scientific validity, analytic performance, and clinical performance.
Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine. In the European Medicines Agency (EMA) view, if the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under Directive 2001/83/EC7 or Regulation (EC) No 726/20048. However, MDR’s Article 117 brought some relevant additions. First, two categories were defined: (a) Integral, where the medicinal product and the device form a single integrated product (e.g. pre-filled syringes and pens) and (b) Co-packaged, where the medicinal product and the device are separate items contained in the same pack (e.g. reusable pen for insulin cartridges). Next, Article 117 also incorporated some relevant amendments to Directive 2001/83/EC to ensure combination products comply with the medical device legislation. Per MDR’s Article 117, the marketing authorization application should include a CE certificate for the device or an opinion from a Notified Body on the conformity of the device (except for non-sterile, non-measuring and non-reusable surgical Class I devices).
Probably as a reaction to the rapid growth of combination products in recent years and the need to bring further clarity in this area, in June 2019 EMA released for public consultation a draft Guideline on Quality Requirements for Regulatory Submissions for Drug-Device Combinations9. The aim of this Guideline is to clarify expectations laid down in Directive 2001/83/EC and address the new obligations in the MDR. EMA makes it clear that the Notified Body assessment and marketing authorization review would not result in duplicate assessments. The former will review the device alone, while the latter will ensure the safety and efficacy of the drug are not compromised by the inclusion of the device part. The consultation period ended in August 2019 and EMA is now due to finalize the Guideline in the second quarter of 2020.
It is also worthwhile making a reference to medical devices which may contain an ancillary medicinal substance to support the proper functioning of the device (e.g. drug-eluting stents). These products should comply with the medical device legislation. Yet, the manufacturer should also seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma, or if it is within the scope of the centralized procedure for the authorization of medicines. For other substances, the Notified Body can seek the opinion from EMA or a national competent authority. Of note, EMA has recently issued a Consultation Procedure for Ancillary Medicinal Substances in Medical Devices.
Companion diagnostics are seen by EMA as in vitro diagnostic tests that support the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment. Applicable regulations were discussed above. Yet, before the Notified Body can issue CE Marking, it must seek a scientific opinion on the suitability of the companion diagnostic to the medicinal product concerned from EMA or a national competent authority, as appropriate. Similarly, a scientific opinion would also be needed for some other medical devices made of substances that are absorbed by the human body to achieve their intended purpose. These devices are normally introduced into the human body via an orifice or applied to the skin. Last, we should not forget the so called “borderline products”. These are complex healthcare products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements. The European Commission publishes the ‘Manual on borderline and classification in the Community regulatory framework for medical devices’ which provides examples and recommendations for determination of classifications. National competent authorities classify borderline products either as medicinal products or, for example, as medical devices on a case-by-case basis based on the product’s composition and constituents, its mode of action and its intended purpose. This determines the applicable regulatory framework.
The new European regulatory environment (MDR, IVDR and EMA guidance on Drug Device Combinations) in conjunction with expanded quality standards for MedTech products and a rapidly changing reimbursement landscape are intensifying the need for a Medical Affairs role in the product lifecycle management. Furthermore, the increased trade organization’s guidelines as well as a more complex competitive environment in which the direct comparator might not be another MedTech product but instead a Drug or a Drug Device Combinations, all work favorably for Medical Affairs to step up its game and demonstrate its value in many regards.
The traditional competencies of Medical Affairs are still required to produce the new mandatory regulatory deliverables (Clinical/Performance Evaluation Report, Periodic Safety Update Report, Summary of Safety and Clinical Performance). However, more than ever Medical Affairs involvement needs to be formalized for various other key processes ranging from product development to device application. In order to give real meaning to patient and customer centricity, the inclusion of Medical Affairs contribution is indispensable with regard to, for instance, risk analyses, claims development and identifying user training needs.
In addition, medical and clinical research functions must lead in the development of coherent and affordable clinical research programs that serve regulatory compliance, reimbursement and commercial adoption purposes. The increased effort the companies must make to generate clinical evidence will undoubtedly put strain on human and financial resources. The careful planning and design of studies should avoid waste in time and money while providing the evidence the business needs in a timely fashion. Therefore, as non-inferiority assessments are giving space to superiority assessments, an increased is expected in reliance for regulatory purposes on less conventional evidence generation strategies such as registries, collaborative research and investigator lead studies.
Furthermore, ensuring the safe application of current devices, medical communication and interactions with healthcare stakeholders and health authorities, collecting and weighing medical intelligence on future directions in healthcare all require medical scientific oversight. The medical scientific oversight will be fundamental in the advancement of the company’s innovation agenda as the bar is higher than ever, as are the associated entry and maintenance costs.
The new environment makes a compelling case for installing a structure for Medical and Scientific Governance and a proactive strategic role for Medical Affairs. This in turn opens the discussion on how to develop and organize competencies around organizational capabilities that relate to the development of innovative and relevant devices, the substantiation of medical-clinical and health economic claims and ultimately oversight to ensure safe and appropriate use. Thus, we argue that now is the time to engage in captivating thought exercises about whether a company’s fabric with a prominent role of Medical Affairs adds to the organizational capability and resilience to handle current and future challenges.
This publication represents the consensus opinions of the authors and various members of MAPS, but does not represent formal endorsement of conclusions by their organizations
1. EU Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. EUR-Lex; an official website of the European Union. Published July 12, 1993. Accessed August 27 2020.
2. EU Council Directive 98/79/EC concerning in-vitro diagnostic medical devices. EUR-Lex. Published December 7, 1998. Accessed August 27, 2020.
3. EU Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, EUR-Lex, Published July 20, 1990. Accessed August 27, 2020
4. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. EUR-Lex. Published May 5, 2017. Accessed Aug 27, 2020.
5. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. EUR-Lex. Published May 5, 2017. Accessed Aug 27, 2020.
6. European Commission. MEDDEV 2.7/1 rev. 4 – Clinical Evaluation: A guide for manufacturers and notified bodies. Website of the European Commission. Released June 2016. Accessed August 27, 2020.
7. EU Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use. EUR-Lex. Published Nov 28, 2001. Accessed Aug 27, 2020.
8. EU Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. EUR-Lex. Published April 30, 2004. Accessed Aug 27, 2020.
9. European Medicines Agency – draft guideline on the quality requirements for drug-device combinations. EMA Website. Published June 3, 2019. Accessed Aug 27, 2020.
This webinar from the MAPS APAC region shares best practices for effectively leveraging patient insights to inform decision making.
Through this course you will recognize terms such as artificial intelligence (AI), machine learning (ML), deep learning, and neural networks to arrive at best decisions and insights needed for success.
As a result of the global COVID-19 outbreak, field teams are no longer able to visit HCPs face-to-face. In order to overcome this challenge and continue to engage their HCPs, Field Medical teams are required to do so virtually via online video platforms. Although practical, this method of communication requires a different set of skills compared with face-to-face interactions, and comes with its own challenges. During this Webinar, we will explore the skills and challenges around effective remote engagement and share hints and tips to help you access, engage and follow-up with HCPs remotely
(a) targeting a predefined set of focus questions
(b) presenting alternate views on a particular issue that is of concern to the Medical Affairs community and attempting to resolve the issue
(c) identifying priorities for new areas of industry standards and guidance
(d) initiating the appropriate collaborations and building community around a theme of interest.
Dr. Qasim Ahmad, Corporate Officer, Head of Medical Affairs, Japan, Novartis
Since joining the pharmaceutical industry (PI) 2 decades ago, I have been lucky to have lived through and experience the exponential growth of medical affairs function, not only in size and ever expanding responsibilities, but also the importance and value it brings to the industry. There are several internal and external factors, contributing in the evolution of medical affairs from a mere support function to becoming a core pillar, and an equal partner with drug development and commercial functions with the PI.
In recent years, we have seen significant and unprecedented advances in biotechnology, delivering novel treatments and data sets, faster than ever before. There is an information overload, which calls for smart and innovative ways to design, analyse, disseminate and communicate the value of evidence, to the right end user (the customers), at the right place and the right time.
Concurrently, health systems across the world are becoming over-burdened, facing considerable sustainability challenges, due financial constraints, ageing, increasing population, changing disease patterns, persisting as well as new communicable diseases (COVID-19) and cost burden of chronic non-communicable diseases, including cancers.
You must also develop command on evolving health care environment and be equipped to meet the challenges associated with growing drug approval complexities and health technology assessment criteria for access. Develop unique competencies and transformative operating models to address these requirements, build capabilities that are ideally suited for medical affairs organization to generate data beyond traditional registration trial safety and efficacy packages, to facilitate evidenced based decisions making based on patient centric, clinically meaningful, health outcomes, access and quality of life real world data (RWD) data sets.
As you think of building your career in medical affairs, keep the above opportunities and challenges in consideration, the following 5 core medical affairs competencies will help nurturing your talent as patient and customer centric medical champions, ready now for future.
1. Enterprise Perspective
Medical Affairs has evolved to be one of the most strategically important and valued functions in a pharmaceutical industry. As successful medical affairs professionals, you need to build the skills and scientific acumen like that of a clinical development expert, while demonstrating the strategic intellect and real life customer oriented mind-set of a commercial leader. You will have to champion cross functional navigation, show enterprise vision, logical and critical thinking, develop broad and long range strategic direction throughout product life cycle and build bridges between unlimited internal touch points as well as external stakeholder.
2. Functional Excellence
In order to demonstrate value, your medical affairs competencies should be geared to exceed internal and external expectations, meeting the demands of above mentioned expanding responsibilities, while acquiring new skills and capabilities. You will need an all-rounder approach, adapting new technologies, digital tools, precision medicine approaches, and introduce novel engagement models. Thus continuously striving for medical and operational excellence, not only in designing and delivering high quality clinical trials based on meaning actionable insights, but also excellence in executing deep scientific exchange with medical experts, incorporating the voice of patient, payer and all stakeholders at launch, and across life cycle strategies.
3. Health System Thinking
In medical affairs, you are perfectly placed to lead, plan and deliver health care solutions and to shape the environment, playing a key role in health systems sustainability. You should build capabilities and competencies to assess health system needs and developing solutions, supporting public health initiatives; disease awareness & educational training programs; research collaborations in area not only limited to company core business (orphan diseases, rare indications, special populations); managed patient access programs and many other patient focused projects, partnering with health system players. You will require special skills for this mind-set shift, and thinking beyond the pill to building trust with the society. This competency is distinctive and vital for future role of medical affairs.
4. External Facing Organization
As part of modern medical affairs organization, you should have involvement and ownership across life cycle of assets, from early development to late stage planning. Either you are in field medical teams, medical advisors or MSLs (medical science liaison) role, you are the eyes and ears of the organization to external world. With external customer base expanding beyond prescribers and policy makers, you well have to learn rule of engagement and proficiency to work with providers, payers, private non-state health actors, patients and patient advocacy groups, as they are all taking central stage in health care decision making. This will be the game changers in reversing the traditional internal fixated industry approach to a strategic patient and customer focused, outward facing organization. Building this core competency by incorporating patient journey, stakeholder need assessment and changing health care limitations in your strategies, will enhance collaborations, speed of innovation, resource waste reduction and improved patient outcomes.
5. Effective Leadership
Modern medical affairs is not a support function, it is about leading from the front as equal partner with commercial, departing from prior passive back seat mind-set and demonstrate value to the organization through proactive leadership, vision and measurable impact. You will have to steer this transformation from current medical advisory role to leadership status, breaking unnecessary internal silos and taking ownership as well as accountability of business deliverable. Creating this new room within the organization will requires your commitment, change agility, interpersonal skills and inspiring leadership to take on completely new responsibilities or replacing those previously championed by other functions.
Conclusion
Traditional sales and commercial models are becoming obsolete, success of future pharmaceutical frameworks relies on vision, foresight and appropriate investment in building medical affairs (MA) talent, ready now for future. With ever changing external landscape, regulations and compliance requirements, the role of medical affairs will continue to grow as the key pillar, vital to achieve organizational objectives. By building these core competencies, you can demonstrate to your leadership, the value medical affairs brings, and its strategic far reaching business impact.
By Alan McDougall, MD, VP, Head of Medical Affairs, Asia-Oceania Region, Astellas
Interviews are stressful but you can reduce your adrenaline levels through proper preparation. Medical Affairs has transformed in the last decade and there are a number of key competencies which are sought after and which you should attempt to demonstrate through each and every contact you have with both the recruiter and your prospective employers. Below is a not exhaustive list of the most desirable competencies and behaviours.
Communication
The ability to communicate clearly and effectively and through a variety of channels is essential for anyone working in medical affairs. Having a high level of knowledge but an inability to share it or teach it effectively is of little value. Communication also includes using appropriate body language, listening skills and the ability to provide feedback. Make sure every verbal or written contact you have with the company or the recruiter is carefully thought through and proof-read in the case of written contacts.
Passion and enthusiasm
Employers want to hire someone who demonstrates a passion to work at their company, sometimes described as being “hungry” for the role. Having the right attitude is often more important than knowledge, because attitude is very hard to train but knowledge can be learned. Carefully word your cover letter and individualise your CV for each job to stress key experiences or skills that are mentioned in the advertisement and job description (JD). Spend time browsing through the company’s corporate website and come armed with pre-prepared questions which are thoughtful and specific to the role and the company. If possible, ask about a recent company press release and the implications (if any) for the role for which you are applying.
Technical skills
Medical affairs positions require certain technical skills that are usually listed in the job advertisement or JD. You should already possess many of the skills the company is looking for, at least to some degree. You may not yet be an expert in all of them but there should be a solid foundation upon which you can build. Typically, at interview, these technical competencies will be assessed (presentation skills, therapeutic area knowledge etc.). Take note of the JD, advert and recruiter’s comments and use every contact opportunity to mention where your current technical skills fit the role being offered.
Work ethic
It should go without saying that employers expect you to be at work on time, do what you were hired to do, meet targets and deadlines and work to the best of your ability. Sadly, we have all worked with colleagues who do not always meet these basic requirements. Make sure you are early for interviews, meet all deadlines when replying to emails, phone messages etc. and do everything you can to give your prospective manager confidence in your own work ethic. You have only a few contact opportunities with your potential next company and so make sure each one says something positive about you and your personal standards.
Flexibility
More than ever before, employees need to react quickly to changing business conditions. Agile companies and agile teams are currently popular subjects in articles written by business thought leaders. Employers need employees who can quickly adapt to change. Come to interview with examples of how you demonstrated your own agility – perhaps covering another role on top of your own, taking on a project about which you had no little or no previous experience and delivering a successful outcome or dealing positively with an unpredictable environmental change.
Resilience
We all typically get challenging but (hopefully) achievable goals and deadlines. The key to successful delivery is often being able to work hard and to keep moving forward when you encounter the inevitable and frustrating obstacles that regularly happen in business. Come to interview with examples of how you overcame particularly difficult challenges and show that you did not give up but that you persevered and ultimately met your objectives.
Teamwork
Little in the pharmaceutical industry is achieved by a single individual. Roles in medical affairs are becoming more diverse and specialised and therefore there is an increasing need for reliance on your colleagues to get things done. The ability to get on and work collaboratively with others is therefore a key competency. Using real examples, show how you contributed to successful teamwork under challenging circumstances and how you “did not give up”.
Life-long learner
As product portfolios and market environments change, there is a need to seek out new information, challenge your beliefs and explore new ways of doing things. Long-held “facts” can change when new contradictory evidence emerges. People who are naturally curious with an interest in learning combined with a willingness to share this with others, make great co-workers. At interview, explain what new skills or knowledge you have learned, how you applied this at work and describe the impact that it made.
Problem-solving skills
Managers look for people who are motivated to take on business challenges, ideally with minimal direction. Most of us prefer our employees to “come to us with solutions not problems”. Employees should see when something needs to be done and react accordingly. Come to interview with examples of how you observed an issue at work, took ownership of it and solved it. This can be even more impactful if it wasn’t in your job description in the first place.
Loyalty
Employers want people to stay with them for many years due to their financial investment with the recruitment company and the time spent on interviews and on your on-boarding process. Multiple job moves in a relatively short time period with different companies is usually an alarm bell and indicates a risk that you will not stay long if you are even offered the job. If you unfortunately have had several short-term moves recently, make sure that you come to interview with a clear explanation as to why and what you learned. Try hard not to criticise your current or previous companies or managers as this can come across quite negatively, even if you feel you have every right to do so. Employers always prefer someone running towards the role on offer than someone running away from their current job as the former is a positive choice whereas the latter can be simply escaping to “any port in a storm”.
Conclusion
It is a truism to say that you only have one chance to make a good first impression and so at interview be well prepared and make sure you have done your homework well in advance. Tell the employer why you really want this job and make sure your passion and enthusiasm come to the forefront. Show your agility, resilience and ability to learn, which are all highly valued competencies by employers. Finally, do remember that all contacts with the employer and recruiter, no matter how trivial, are likely to be judged so make them count!
By Cezary Statuch, MD, VP, Medical, International Markets, Biogen
Like many things in life, when managing your career timing is everything, and being in the right place at the right time is important. Knowing whether it is the right time for you to move on is not always easy. The pharma and biotech industries are an attractive place to pursue your professional dreams, and some markets are in great demand for medical affairs talent–so the phone rings more often than ever with calls from headhunters. Unfortunately, at times of high demand for talent the recruiters are less likely concerned if you have completed your career cycle, and if your skill set fits what they are after you will have to deal with serious temptations. Here are a few tips on how to manage your career planning and how to get ready for your next job.