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Shilpa Medicare Limited – Interviews in Pharma Telephonic for Production, Purchase

Shilpa Medicare Limited – Interviews in Pharma Telephonic for Production, Purchase

Interviews in Pharma

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We are proud to assert that trust and commitment of our more than 1000 employees drives our growth and success.

Shilpa Medicare aspires to be the best and strives to consistently rise above the regular. Interviews in Pharma We challenge ourselves on a daily basis, continuously seeking to exceed expectations, while remaining accountable for everything we do. Taking the lead and outperforming our own best capabilities ensures success in all we pursue.

We place great value on diversity and inclusion and foster an environment of equal opportunity. Interviews in Pharma We also empower our employees to take responsible risks to help us live up to our promises and achieve our goals. We firmly believe that for success of an organization nothing is more important than its employees. We make sure that skills of our employees are continuously upgraded thus supporting the sustainable growth of the organization. We are constantly focused on making our work-place one that is ambient for the best performance of our employees.

We look for the best when hiring and are always ready to consider hard-working and self-driven individuals who are willing to share our commitment for leadership. If you feel that your profile, career goals and attitude fits our bill, you are welcome to share your detailed profile with us by applying online or by sending an e-mail to [email protected]

The pharmaceutical field offers a wealth of job and career opportunities for talented young graduates with a sound background in life sciences and various other academic disciplines. Interviews in Pharma Because these employment options are often insufficiently known to young academics, the aim of this chapter is to give them a better idea about the many job opportunities and presents the entire drug life cycle. The first part of the chapter includes a general description of the drug life cycle and what is understood by ‘the pharmaceutical sector’. The core of the chapter gives an overview of job opportunities that either are specific to the different parts of the drug life cycle or are important as support functions over the entire life cycle. It also includes a section on career perspectives and training opportunities. The last part of the chapter focuses on important employability elements, as well as some practical do’s and don’ts for effective job application.

Job opportunities and Interviews in Pharma throughout the drug life cycle

In this section, we walk through the drug life cycle and focus on job opportunities that are specific to the different parts of the cycle. Support functions that are important over the entire cycle are presented in Section 5.

4.1. Discovery research Job opportunities and Interviews in Pharma

Drug discovery research is either phenotypic-based (empirical and response-driven) or target-based (molecular and hypothesis-driven).

Although the phenotypic-based approach has been very successful in the past, today’s drug discovery is more target-based. Interviews in Pharma The process is as follows: (1) selection and validation of a (druggable) target, mostly a protein (e.g. receptor, enzyme, ion-channel and antigen), but also carriers of genetic information (e.g. DNA/RNA and oncogenes); (2) development and validation of a proper assay, allowing to study the interaction between the target and potential drug candidates; (3) (high-throughput) screening (HTS) of potential drugs, generated through de novo synthesis or from existing natural or chemical libraries, in order to identify ‘hits’ (interactions with the target); (4) hit-to-lead finding, i.e. limited optimisation of drug candidates in order to identify a limited number of promising lead compounds; (5) lead optimisation, with the objective to improve target selectivity and specificity, as well as the pharmacodynamic, pharmacokinetic and toxicological properties of the candidate drug, in order to get it ready for development.

Drug discovery research is highly dependent on the interplay between different scientific and other disciplines. In practice, it includes intensive collaboration between mainly:

  • different types of biologists, such as molecular biologists, biochemists, biotechnologists, bioinformaticians and biomedical scientists;

  • different types of chemists, such as medicinal chemists, combichem specialists, computer-assisted drug designers, protein chemists and analytical chemists;

  • pharmacologists, pharmacokineticists, pharmacometricians, toxicologists, biopharmacy and pharmaceutical technology experts;

  • as well as representatives of other disciplines, such as (bio-)engineers, data analysts, intellectual property (IP) specialists and patent lawyers.

 

Drug research departments may be organised per therapeutic domain (more specialised and more compartmentalised) or rather more ‘holistically’ per biological platform, such as a similar target family (e.g. kinases and ion channels), or a similar biological mechanism (e.g. angiogenesis, inflammation, cell cycle control and epigenetics), or per common technological platform (e.g. 3D modelling, X-ray crystallography and NMR spectroscopy).

Innovative drug research organisations (pharmaceutical companies, academic centres, spin-offs, or start-ups) are looking for highly educated and talented individuals with at least a master’s degree and preferably a PhD in the aforementioned disciplines. However, being an excellent scientist is not enough to be successful in this field. You also need the right creative mindset, being able to think out of the box and to work together in a multidisciplinary team on a specific project for several years.

Discovery research is the least regulated phase of the drug life cycle and confers to professionals working in this field a fairly high degree of freedom, although in the competitive world of today, research teams also have to deliver quality products, in time and within budget.

As drug R&D is costly and risky; drug candidates are patented so that they later gain market exclusivity without competition for a set period (in general, 20 years after patent filing). Therefore, drug research organisations as well as national and international patent offices also offer job opportunities for IP specialists, such as patent lawyers and patent reviewers.

4.2. Non-clinical development Job opportunities and Interviews in Pharma

Non-clinical drug development, including all experiments not involving human subjects, is an umbrella term referring to the following activities: chemical and pharmaceutical development (also known as ‘chempharm’ or ‘chemistry, manufacturing and controls (CMC)’), experimental pharmacology (including safety pharmacology), non-clinical toxicology and non-clinical pharmacokinetics.

It is essentially a lab activity, involving in vitro and in silico research as well as animal experiments. Its goal is to generate the data needed as prerequisites for the different clinical development phases (the preclinical part of non-clinical development), all the non-clinical data for the marketing authorisation application (the preapproval phase), as well as all the non-clinical data during the continued development when the drug is already on the market (the post-approval phase). Non-clinical development is much more regulated than discovery research and has to be executed within a framework of international guidelines (ICH Quality and Safety guidelines) and according to the international standards of good laboratory or good manufacturing practices (GLP and GMP).

Chemical and pharmaceutical development, including drug (product) manufacturing and drug (product) analysis, offers opportunities especially for analytical and green chemists, chemical or bio-engineers, pharmaceutical technologists and (industrial) pharmacists.

Non-clinical efficacy and safety pharmacology units are rather looking for experimental pharmacologists, biomedical, or (bio-)pharmaceutical scientists.

Non-clinical pharmaceutical toxicology departments are essentially in need of toxicologists, veterinary surgeons and pathologists, but can also do well with interested biomedical or (bio-)pharmaceutical scientists.

Non-clinical pharmacokinetics departments are especially looking for pharmacokineticists, experts in drug metabolism and bio-analytical chemists. Interviews in Pharma As model-based drug development is booming, there is also a high need for pharmacometricians, modelling and simulation experts, or more generally, biomedical or (bio-)pharmaceutical scientists with a sound background in mathematics.

For most executive functions in all the above-cited fields, having a master’s degree is an absolute must and a PhD a big plus, although a lot of lab technicians are also welcome.

Non-clinical drug development specialists are also needed in (inter-)national medicines agencies as assessors of the CMC (quality) and the non-clinical (safety) parts of the common technical document (CTD), the international harmonised dossier for application of a marketing authorisation of pharmaceuticals for human and animal use.

4.3. Clinical development Job opportunities and Interviews in Pharma

Clinical drug development, defined as all studies involving human subjects, is (because of its complexity and long duration) usually subdivided into different phases.

It starts classically with small-scale phase 1 studies, including the First-in-Man or First-in-Human (FiM/FiH) study, the single ascending dose (SAD) and the multiple ascending dose (MAD) studies, usually in healthy volunteers (but sometimes in patients), in order to have a first impression of the safety, pharmacokinetics and pharmacodynamics of the drug in development in humans. Then follows phase 2a, to investigate whether the drug works at all in patients according to the presumed mechanism of action (the so-called Proof-of-Concept or POC study) and to have a preliminary idea about the effective and safe dose range in tens of patients with the intended indication. Nowadays, phase 1 is often preceded by a phase 0 study with a limited number of subjects, with a single radioactive microdose of a limited number of drug candidates in order to help researchers in the selection of the best candidate for further full development. In a more recent classification, the preceding phases are together defined as ‘early’ or ‘exploratory’ clinical drug development. The corresponding ‘late’ or ‘confirmatory’ clinical development phase is then corresponding to the classic phases 2b, 3 and 4. The main objective of phase 2b is proper dose (regimen) finding in hundreds of patients with the targeted disease, whereas phase 3 clinical trials aim at confirming a positive clinical benefit/risk balance versus existing therapies in thousands of patients. If successful after this phase, a marketing authorisation application is filed, allowing the drug, if granted, to be put on the market and generate return on investment. This part of the late development phase is also called the preauthorisation or preapproval phase. Finally, in phase 4 of clinical drug development (the post-authorisation or post-approval phase), the use of the drug in everyday clinical practice is studied, its pharmacovigilance (adverse drug reactions) is (are) monitored and new developments are initiated (for new indications, new associations, or new formulations).

Clinical drug development also involves many different disciplines, each offering several job opportunities. Within clinical drug development organisations (e.g. pharmaceutical companies and CROs), they are usually grouped in the following departments: Clinical Research, Clinical Operations, Medical Review and Pharmacovigilance, Clinical Biometry and Clinical Services, although names can vary from company to company. Their role is to extensively collaborate with one another and generate all clinical data for the marketing authorisation application (preapproval phase), as well as all clinical data for continued developments in the post-approval phase.

Clinical Research Interviews in Pharma is responsible for the content of the clinical development plan of the new drug.

They define the strategy, do the planning, oversee the methodology and coordinate the overall (worldwide) management of all clinical trials. In the early clinical development phase, they primarily need clinical pharmacologists, clinical pharmacokineticists, clinical pharmacometricians, but also clinicians (either medical specialists or general practitioners). Interviews in Pharma In the late clinical development phase, this need shifts more towards clinicians and pharmaceutical physicians, pharmaco-epidemiologists and (hospital or clinical) pharmacists.

Clinical Operations is in charge of the implementation of the clinical development plan, the local project management, as well as the monitoring and administration of all clinical trials.

Interviews in Pharma They typically hire international and local clinical trial managers, clinical research associates (CRAs or monitors) and clinical trial administrators (CTAs), often with just a master’s degree in life sciences (e.g. biomedical or pharmaceutical scientists, research nurses, physiotherapists, or even physicians).

The Medical Review and Pharmacovigilance Department is populated by medical reviewers and pharmacovigilance (PV) experts, responsible for the critical review of all medical data gathered in clinical trials and especially all data on adverse events and adverse drug reactions.

Interviews in Pharma These aspects are best handled by (pharmaceutical) physicians (hospital or clinical) pharmacists and clinical toxicologists, with the external help of clinicians and medical specialists for specific problems.

Interviews in Pharma The Clinical Biometry unit, Interviews in Pharma in charge of clinical data management and clinical statistics, is particularly looking for clinical trial methodologists, data managers, (big) data analysts, biostatisticians and computer programmers.

And finally, the Clinical Services Department Interviews in Pharma is responsible for the supply and logistics of all clinical study material, e.g. supply, storage and shipment of investigational drugs (including placebo and comparators) and central laboratory materials (to and fro the study centres, all over the world), or provision of standardised study equipment (e.g. a treadmill for exercise tolerance tests, including the software to run the test).Interviews in Pharma  They usually hire pharmaceutical or biomedical scientists for these jobs.

Interviews in Pharma Clinical drug development specialists are also needed in (inter-)national medicines agencies as assessors of the clinical parts of clinical trial or investigational new drug applications (CTA in Europe, IND in USA) and Marketing Authorisation (MA, Europe) or New Drug Applications (NDA, USA).

A particular characteristic of clinical drug development is that clinical trials are largely performed in investigational sites that do not belong to the drug development organisation itself.Interviews in Pharma With the notable exception of phase 1 trials, usually performed in phase 1 units with healthy volunteers (of which some are owned by pharmaceutical companies or CROs), clinical trials recruit patients who can only be found in institutions, e.g. (university) hospitals, academic phase 1 units, or nursing homes, or else in private practices of general practitioners or medical specialists. Besides, many (academic) hospitals perform their own clinical (drug) research as investigator-initiated trials (IIT). Interviews in Pharma All these investigational sites also offer a lot of job opportunities as investigator, research physician, research nurse, study coordinator and clinical research pharmacist. Interviews in PharmaSome sites are grouped in site management organizations (SMO) or specific organizations such as the European Organisation for Research and Treatment of Cancer (EORTC) that coordinate clinical trials for their member sites. They too need qualified professionals.

4.4. Commercialisation Job opportunities and Interviews in Pharma

The last part of the drug life cycle and hopefully the longest for many years, is the commercialisation phase. It starts with the marketing authorisation of the new medicine and ends with its withdrawal from the market, thus also ending its life cycle (see Figure 1).

Interviews in Pharma During this phase, there is a period that an innovative drug can be on the market without competition thanks to its patent protection and additional exclusivity rights, so that the owner can maximise its return of investment (ROI). Once off-patent, sales in general suddenly drop (the patent cliff) because of the introduction of generics or biosimilars, but may find a new equilibrium for years thereafter.

Drug commercialisation activities are mostly the prerogative of pharmaceutical companies, although some can also be subcontracted to CROs. They can be found in the following departments: market access, marketing, medical affairs, production and distribution and sales.

A marketing authorisation is not sufficient to get a drug for human use on the market. You also need to negotiate a fair price with different national health authorities (price setting) and to demonstrate added value in order to gain acceptable coverage or reimbursement conditions with different national health insurance system providers. These steps are known as market access hurdles. Interviews in Pharma Market access departments Interviews in Pharma mainly group financial experts, drug pricing specialist, experts in health technology assessment (HTA), pharmaco-economists, core value dossier writers and pharmaceutical policy experts, together with marketing specialists. They generally hire professionals with specific qualifications such as Master of Finance or Economics, but also life scientists (pharmacists, physicians and biomedical scientists) often with a second degree in, for instance, health economics or pharmaceutical medicine. Similar jobs can, of course, also be found in the national institutes, agencies, or committees that have to decide on drug prices and reimbursement conditions.

Pharmaceutical marketing Interviews in Pharma is responsible for promoting the sales of a (new) medicine. It supposes a good knowledge of the pharmaceutical market, general marketing principles (communicating the value of a product to customers), specific pharmaceutical marketing principles (e.g. operating in a regulated market), as well as the specificities of pharmaceutical marketing activities (market analysis, marketing strategy and plan, marketing channels and tools) adapted to the different phases of the commercial life span of a drug (prelaunch, launch, ascending phase, maturity and end-stage phase); and all this, within the rules of local drug promotion, legislation and regulation. This is typically the work space of national or international product managers and brand or group product managers (responsible for several drugs within a given therapeutic area), either specialists with a marketing degree or life scientists with a Master in Business Administration (MBA).

Medical affairs  Interviews in Pharma focuses on clinical drug development in the post-approval phase and on the medical and scientific aspects of pharmaceutical marketing, such as managing medical communications and publications, key opinion leaders (KOLs) and advisory boards and medical information (answering questions from health care providers and patients).Interviews in Pharma  Medical affairs professionals bridge the gap between R&D and marketing and hold positions such as medical advisor, medical science liaison (MSL), medical information manager, or pharmacovigilance expert, usually filled by physicians or pharmacists, often with a postgraduate degree in pharmaceutical medicine.

Pharmaceutical sales and Interviews in Pharma is the ultimate activity that brings in the money to reinvest in new drug R&D. Interviews in Pharma The sales teams are made up of pharmaceutical sales representatives or (medical) reps, who promote (a selection of) the drugs of a pharmaceutical company. Prescription drugs are promoted toward physicians, while non-prescription drugs (over-the-counter or OTC medication) is promoted toward pharmacists. Sales reps are usually responsible for a given franchise or therapeutic class of drugs, a given target audience (private practices or hospitals) and a given local territory. There work is supervised by regional and country sales managers. Most pharmaceutical companies have their own sales force, but additional sales reps can either be (temporarily) insourced from a CRO, or the entire sales activity for a given franchise or brand can be outsourced to a CRO. Sales departments typically hire holders of bachelors and masters in life sciences (including physiotherapists), with strong communication skills and the necessary motivation and stamina to reach sales objectives, which are trained in-house and on the job.

Finally, pharmaceutical production facilities make sure that the necessary volumes of medicines are manufactured in due time with high quality, from the active pharmaceutical ingredient (API) to the end product. The distribution department sees to it that drug orders are channelled appropriately in order to reach wholesalers, community and hospital pharmacies on a regular basis. This is typically a world of chemical engineers, industrial pharmacists and supply chain managers.

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