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Packing the essentials for the Graduate Recruitment Center

Category: Business IT Business Processes European Business Management European Finance Global Finance Global Marketing Global Procurement International Operations Business International Operations Finance Product Supply R&D Global Development R&D Regulatory Affairs | (3) comments

The graduate recruitment center, also known as “GRC” in the Novo Nordisk language of abbreviations, is right around the corner! Congratulations to those of you who has made it so far.

BLOG GRC

I remember thinking last year, what should I prepare and what should I bring? Well let me give you a few tips on how to prepare and pack for the GRC!

The elements for success when packing your “bag” for the GRC:
1. Your Notes and preparation
While you are not asked to prepare anything in particular for the GRC, I would highly recommend that you do your research. By that I mean, do read up on Novo Nordisk, perhaps read the newly released annual report and get a feel for the pharmaceutical industry. Secondly, by preparation and notes I also mean your own “presentation” – you can expect to network and meet several people who will expect to hear who you are in a short 1 minute pitch. You will also have the opportunity to meet a lot of current graduates and employees, use this time to ask what it is like working at Novo Nordisk and prepare those questions you would like to know. This is not only your chance to pitch yourself, but also to get to know what it is like working at Novo Nordisk and see whether this could be something for you.

2. Time keeping – bring your watch!
The GRC is quite full of activities and each of you will get an individual schedule for you to keep with you and coordinate your various events throughout the GRC. Don’t worry, we even have a map for you prepared so you can find your way around and be on time. That said, you will participate in several events and tasks that require some timekeeping. Secondly, time goes fast and you will be very tired by the end of the first day – so do make sure to get a lot of rest the day before so you are ready and rested.

3. Your best shoes!
Now this does not mean you will do a lot of walking, and you should of course be comfortable, but I do advice to remember this is a job interview. Several ladies have already asked, should I wear heels? Well, wear what is comfortable to you, but I would if I was in your shoes :)

4. Talk, talk and contribute
When you reach the GRC, you will already to an extend have had the opportunity to present yourself and your personality, and while this is still very essential for succeeding – another very important aspect at the GRC is your teamwork and how you collaborate with others. Expect to work in teams and get to know the other applicants and possibly future colleagues.

All in all, the GRC is a very challenging, fun and exciting experience that either way will be a great learning experience. So when you roll in with your suitcase or bag, have fun and enjoy that you have made it this far! :)

See you there!

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10 things to pack with you for the graduate recruitment center!

Category: Business IT Business Processes Chinese International Graduate Programme European Business Management European Finance Global Finance Global Marketing Global Procurement International Operations Business International Operations Finance Product Supply R&D Global Development R&D Regulatory Affairs | (0) comments

“How can I best prepare for the GRC?” This is the question that all of you who reached out to me asked. Fair question, as I asked the exact same to a graduate last year a few days before going to the GRC!

Well… I may disappoint you, but actually there is not much you can do in terms of preparation for the GRC. Of course, this is taking for granted that you already know yourself and your CV very well as well as what we do at Novo Nordisk.

Nevertheless, I’d advise you to bring along with you:

  1. Full batteries (energy)
  2. Strong motivation and great enthusiasm
  3. Open-mindedness
  4. Humility
  5. TEAM spirit
  6. Enjoyment and positive attitude
  7. Professional behaviour
  8. Strong awareness for business ethics
  9. Your ambitions and your dreams (everyone has a dream!)
  10. Your TRUE self!

As you read the above list, you may think that it sounds very obvious to pack these things in your suitcase. However, we will be happy to see that you did not forget them at the GRC!

4 additional tips:

  • “How should I dress up?” You have been told that the dress code is “smart casual” meaning that you should dress up appropriately and professionally, yet not too formally. My advice is to dress up in the clothes you feel most comfortable and self-confident with.
  • Enjoy the GRC! Be relaxed (it is very important!) and enjoy every moment that the GRC has to offer you. Although it is going to be intense, be in a positive mood. I have no doubt that you will greatly enjoy your time there anyway. Take it as a unique opportunity to meet amazing people from all over the world and expand your network. I have stayed in touch with quite a lot of people that I met at the GRC last year!
  • For non-Danes – Consider the GRC as an opportunity for you to learn more about Novo Nordisk’s identity and to get some insights on the Danish/Scandinavian culture and work environment.
  • NO STRESS! – I must admit that, even though I was very attracted by Novo Nordisk before applying for the graduate programme, the GRC was the actual revelation for me. On the first day, I realised that I had a big crush on the company (yeah, I’m also romantic when it comes to jobs!) and I left Copenhagen thinking that I really wanted to work for Novo Nordisk one day… However, it was impossible to assess whether I had a chance to get the job or not, as all the candidates I had met there were amazing. Therefore, on the first night in my hotel room, trying to fall asleep after an intense day, I decided not to put any pressure on myself to get this graduate job. I would just be relaxed, cool, and happy to be there with smart and nice people surrounding me. Why? Because I realised that I would like to work for Novo Nordisk one day. One day could be the following September (by starting the graduate programme) or in a few years, coming back with some experience via another job. Nothing is set in stone in life! So if it doesn’t work now, it could work later. NO STRESS! :)

Congratulations again for making it that far and all the best for the GRC! I am looking forward to meeting you all on Wednesday night at the dinner!

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Data management – your way to a career in global development?

Category: R&D Global Development Uncategorized | (4) comments

Dear reader,

Today I bring an interview with Jennifer, the skill area coordinator of the data management program. This is the first time positions are open for data management graduates and I encourage everyone to learn a more about this exciting opportunity below.

Tell us Jennifer, what does it mean to be a data manager?
In Data Management, our activities are spread across the lifecycle of a clinical trial, with deliverables during the start-up, conduct and closure of clinical trials. In short, we develop the databases used to collect data in our clinical trials as described in our study protocols, and we ensure that the data collected is of the highest quality for analysis and reporting.

Can you give an overview of how data management is set-up in Novo Nordisk?
We’re a global organization. We cover all aspects of Data Management at Novo Nordisk at locations in Denmark, India, and the United States. We invite readers to apply and find out more.

What is the most exciting part of being a data manager?
I would say that it is the chance to work directly with our clinical data, which is a most valuable asset—it gets our products to market. As a Data Manager, you are an integral part of the study team, and you will get to make a real contribution to getting our products on the market and out to people with diabetes, haemophilia, and growth disorders. Data management is fast paced and no two days are ever the same.

Who should apply for the data management graduate program?
I would say people who are interested in working with data and complex IT systems, who have an analytical, problem-solving mind-set, that would enjoy being part of a talented, diverse, and fun group of individuals from across the globe. We are looking for people who can drive projects firmly and fairly, with global competencies, and a flair for global networking. We seek individuals interested in making a difference in the lives of those with diabetes, haemophilia, and growth disorders. And of course, apply if you are interested in getting a running start on your career – the program is a great opportunity. If only there had been these types of programs when I was a new graduate!

Data management sound interesting? Don’t miss the opportunity – learn more and apply here

All the Best,
Lars

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A taste of epidemiology

Category: R&D Global Development R&D Regulatory Affairs | (13) comments

Dear reader,

In this blog I’ve invited Johanne, the skill area manager for the epidemiology graduate programme, to give you a taste of what epidemiology in Novo Nordisk is about. Johanne was herself a epidemiology graduate which gives her unique experience that will surely benefit future epidemiology graduates.

It’s a little more than 3 years since you joined the graduate program yourself. Why did you join the graduate program?
I applied for the graduate program in 2012, because it was in my view a very nice way to start my professional life as a “fresh-out-of-university” epidemiologist. I was curious to learn, how I could use the epidemiological skill-set acquired during my studies in the context of a pharmaceutical company. Also, I had my eye set on Novo Nordisk as a great potential workplace, and the graduate program provided a unique opportunity to get an overview of the company through rotations in three different departments.

What did your three rotations in the graduate program look like?
I spent my first rotation in the Epidemiology department in Søborg (DK), where I worked mainly on literature-based tasks related to our main disease areas such as diabetes and obesity. My second rotation took place at our US affiliate office in Princeton, NJ where I was situated in the Health Economics and Outcomes Research department. Here, I worked on the more costs-related aspects of the diseases that Novo Nordisk develops treatments for, as well as the value propositions of our products. Finally, I spent my third and final rotation in Corporate Stakeholders Engagement in Bagsværd (DK), where I worked on a programme on the interlinking between urbanisation and diabetes, “Cities Changing Diabetes”. My role was to provide and validate epidemiological evidence, facts and figures used in the external communication of the programme.

What is special about epidemiology in Novo Nordisk?
I think that one of the special features about working with epidemiology in Novo Nordisk is that it is naturally centred on our main disease areas diabetes, obesity, haemophilia and growth disorders, so you really get to know the epidemiology of these diseases very well. Methodologically, both literature reviews and data analyses are tools that are applied to a high extent, so you really get to use your epidemiological toolkit. In Novo Nordisk we work across the organisation with many different stakeholders and often with quite short timelines for delivery of analyses. Therefore, working with epidemiology in Novo Nordisk often means balancing many different projects and at times a need for a slightly pragmatic approach to the level of detail, even though we always strive for a high methodological and scientific standard.

As a skill area manager, what will you look for in a coming epidemiology graduate?
First of all, I will look for a passion to work with epidemiology and a strong analytical skill- and mind-set. Then I will be interested in knowing about any relevant work experience that the candidate has gained through internships, student assistant jobs or volunteering. International experience obtained while studying or working is of high value as well. Due to the many stakeholder interactions and since we work in teams, it is also pivotal that the candidate has strong social skills and functions well in team work. Finally, I will look for the person behind the application – why does the candidate want to work for Novo Nordisk, what motivates the candidate and what can the candidate bring personally to the company besides strictly professional skills.

If you want to kick-start your career in epidemiology this should give you plenty of reason to consider the graduate program. More about the other programs coming up soon.

All the Best,
Lars

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Trial Management – a perspective from Australia

Category: R&D Global Development R&D Regulatory Affairs | (10) comments

Dear reader,

In this blog post the focus will be on trial management. As I’m not an expert on this area I’ve asked my graduate colleague Maja some questions. Maja joined the graduate program as a trial management graduate in 2014 and is currently spending a very exciting rotation in Australia.

Maja in Sydney.

Maja in Sydney.

Too start off Maja, give us a short introduction to what trial management is all about?
Clinical trials are an important part of the development of new drugs. Before a new potential drug can be put on the market for the benefits of the patients, the product needs to go through a set of clinical trials, making sure the drug is both safe and is working as it is intended.
A clinical trial is a big setup that needs a large amount of planning, organisation and collaboration across different skill areas. In trial management you are responsible of managing this process; from the very first step of writing the trial protocol and orchestrating the roll out of the trial, all the way through to last-patient-last-visit and database lock. From here the collected data is handed over to statisticians and medical writers, preparing the clinical trial report that is sent to the health authorities for approval.

Very interesting. So what has your role been in your second rotation?
In my second rotation, which I have spent in the Australian affiliate, I have been working as a CRA (clinical research associate) also referred to as a monitor. In this role I have got to experience how the clinical trials are run in a local market. Orchestrated from HQ the clinical trials are run locally by the local trial managers and a set of CRAs, who goes out to the clinical trial sites to oversee that the trials are run according to the protocol and good clinical practice.
I have been lucky to be involved in different trials at different stages, allowing me experience both the initiation, execution and closure of a trial. This has given me an insight to all of the processes from A to Z it takes to run a trial in Australia.

maja in australia3 (4)

Which competencies do you get in your current role in Australia that you cannot get in HQ in Denmark?
In the affiliate I have got the opportunity to get a local perspective of how Novo Nordisk as a company operates in Australia and to experience the local aspects of how clinical trials are run in Novo Nordisk. The learnings I have got here I couldn’t gain in any other way than actually being physically situated in the local market. By living and working here, you get this special insight, which you cannot get from reading about it or through other peoples learnings.
Also, through my work in the affiliate I have got to work directly with the customers of Novo Nordisk, in term of investigators and study personnel, which is a type of stakeholder I wouldn’t get to work directly with in HQ.

What is the best part of having an international rotation?
The best part of the international rotation, I would say, is the personal development you gain from having to settle in a new country, a new culture and a new working environment. It requires a lot of investment in the beginning having to build new routines and a new network, but the learnings I have acquired from this experience I am sure I will use in my life going forward – approaching the world with open-arms and a feeling of “I-can-do-this”.

Why should recent, or soon to be, graduates apply for the trial management graduate program?
I definitely encourage everyone with an interest in clinical trial management to apply for the programme! The programme allows you to obtain great knowledge of clinical trials and on specifically how clinical trials are run in Novo Nordisk. Through the programme you get the opportunity to be exposed to different trials in different phases and different therapeutic areas within a short time, which I see as one of the greatest benefits of the programme. On top of this the extensive support and training you get throughout the programme, I find, helps you climb the steep learning curve and transform from a student to an employee, much faster than if you were hired into a position as a regular employee.

Hope you enjoyed Maja’s insight. Stay tuned for more information about the other graduate programs in Global Development.

All the Best,
Lars

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Biostatistics – what does it mean?

Category: R&D Global Development R&D Regulatory Affairs Uncategorized | (1) comments

Dear reader,

My previous blog post was an introduction to the graduate positions that are offered in Global Development this year. When you apply for the Global Development graduate program you will apply for a position in one of six different skill areas. There are some common elements to these positions and ultimately you will be working towards the same goals in global development no matter which position you have. However, it is important to know in which area you can make the biggest difference with your current skills. In the coming weeks I will upload some blogs describing what the different skill areas are all about.

I will start by telling about my own area which is biostatistics. Currently I’m working on a clinical trial which has been ongoing for 5 years and is about to close down. We are now in the hectic phase of discussing how the data should be presented and creating the statistical output summarizing and visualizing the data. When this process is complete the data will be presented to GD management and form the basis on which they take business critical decisions. When this is done publications of the results and other exploratory analysis will be prepared for major medical journals. All of this work is done in close collaboration with medical doctors and scientists who are experts on how the drug works and how it affects the patients. Furthermore, it is important to have a dialogue with the authorities which approve the drug. Ensuring that we comply with the requirements set by the authorities is something that affects all the work done in biostatistics.

Another important aspect of the work I currently do is to ensure that the way we analyse and interpret data corresponds with the way it was actually reported by the patients in the trial and the doctors conducting it. This can especially be a challenge with a trial which have been planned more than 5 years ago. It necessitates a close collaboration with the data managers, who are responsible for collecting the data in the trial, and the trial managers, who are responsible for the organization of the trial.

Now these are only some of the tasks which we do in biostatistics. Another example of tasks we perform is providing statistical evidence that support the price negotiations conducted by our health economics colleagues. In general it takes at least 3-5 years of biostatistics experience to get through all the processes biostatistics is involved in. Being a part of the biostatistics graduate program will give you the opportunity to do at least two 8 months rotations in biostatistics. This gives you the opportunity to get exposure to more of the processes biostatistics are involved in while also allowing you to try out different projects. If you have an interest in the pharmaceutical industry, don’t let this opportunity pass!

All the Best,
Lars

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6 ways to a life changing career within Global Development

Category: R&D Global Development R&D Regulatory Affairs Uncategorized | (15) comments

Today I had a Skype call with my Programme Manager, Kristina Jacobsen.

I am currently located in Bangalore, India and she is seated in our Headquarter in Denmark.

Kristina was very happy and told me that the hiring process of 12 new graduates will be initiated shortly. Whereas most Novo Nordisk graduate programmes hire every year Global Development only hire graduates every 2nd year. So now is a unique chance to apply if you would like to join Global Development!

The next group of graduates (application period 01-DEC-2015 to 10-JAN-2016) with a joining date of 01-SEP-2016 will expand significantly.

We are currently 7 GD graduates spread on 3 different skill areas; Biostatistics, Trial Management and Health Economics. Going forward, the GD Graduate programme will consist of 12 graduates covering 6 different skill areas:
• Biostatistics
• Statistical Programming
• Epidemiology
• Medical Writing
• Trial Management
• Data Management

I was really excited to hear this news as it will give an additional 12 future graduates a chance to embark on a life-changing career within Novo Nordisk.

The focus in Novo Nordisk is the development of life-saving treatments and this is surely something to be proud of. More than 90 years of experience working with innovative biological medicines and understanding patients´ lives allows Novo Nordisk to concentrate on areas where we can make a real difference. In Global Development, we lead the clinical activities from when a drug candidate enters clinical testing through the submission and approval phase and when it has entered the market. On top of this, everybody is encouraged to contribute and share new ideas. The flow of knowledge across teams is highly supported and there is a healthy and engaging working environment.

Kristina confirmed that the set-up for the new graduates will be similar to the existing one, where each of the skill areas have an experienced specialist assigned who is responsible for planning the rotations and ensuring a steep learning curve throughout the 2 year period for each individual graduate. This special set-up is very beneficial and shows the commitment in Global Development towards the professional and personal development of the graduates.

As a programme manager, Kristina is responsible for the overall coordination of the programme during the 2 year period. Furthermore, she is responsible for common activities for all GD Graduates such as conducting monthly touch base/knowledge sharing sessions and evaluation meetings. Kristina and I talked about the great privilege of being part of both formal and informal graduate networks which allows us all to broaden our learnings even further while building networks and relationships across the company. We surely have a lot of fun and good laughs when we meet.

Kristina mentioned that she is looking very much forward to welcome a new group of young talents to Novo Nordisk. I can only echo her. If you are ready for a life-changing career, now is the time to apply!

 

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2-years as a RA graduate and then what?

Category: R&D Global Development R&D Regulatory Affairs | (3) comments

I believe that the graduate blog is very successful in providing an insight into how the programs work, the experience one has during the program and how one can manage to get accepted into the program; however there is less information on what happens after the program.

So you sign up for two years of rotations and new impressions; being pushed outside your comfort zone every 6 or 8 months (depending on the program) and then what happens?

Let me start by saying that you sign a two-year contract meaning your are not bound to the company after the program ends but also they are not required to keep you (this does not apply for the IO programs). Having said that, the company invests a great amount of resources into its graduates and thus you should be offered a position after the two years if you manage to meet their expectation.

The retention rates of graduates differ between the programs and I believe RA has the highest rate with 100% of former graduates still working for Novo Nordisk. In general Novo Nordisk is very successful in keeping its employees and creating a working environment one just does not want to leave again.

So what happens to RA graduates after they finish the program?

In most cases the next step will have already been finalized months before the 2-years come to an end and you will transition smoothly from your ‘graduate position‘ into your ‘permanent position‘. Often this involves a change in department; however some graduates have chosen to stay within the department they selected for their third rotation.

How easy it is to find a department after the program depends on how well your interests meet the current business needs. Nonetheless the fact that all RA graduates are still within the company shows that they try to give you the possibility to work exactly where you want.

As an RA graduate you become an RA professional after the program and then there are three main development paths which are shown in the figure below.

blog pic 4

The specialist role features in-depth analysis and investigation into a specific area of RA, involving solution-seeking and method/process-optimization. On the other hand the line manager role is defined by setting targets and directions; it involves a great extent of people management and development to achieve results. The project-management track is the most-cross functional as teams are built with key players from diverse disciplines to manage and see through a product from early development stages to life-cycle management.

Therefore one has many opportunities to find a role matching one’s interest. In general Novo Nordisk puts a lot of emphasis on personal development also outside the graduate program and managers are very responsive towards employees’ wishes.

Lastly let me end by saying that the program does not guarantee that everyone will end up as CVP but it provides one with a fast track opportunity to explore different fields and roles aiding your future development.

If you do not want to miss the opportunity to become part of the program send in your application now and use these blog posts to help you in structuring your application (FAQ, Cover Letter, Application 1 + 2, Last Minute Tips).

 

 

 

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The Ups and Downs of the Rotation Abroad

Category: R&D Global Development R&D Regulatory Affairs | (10) comments

At the beginning of the month I took the chance to sit down with the two RA graduates Mark and Sascha that have just returned from their rotation abroad. Throughout our one hour ‘coffee’ meeting that involved a lot of cake (my favorite type of meeting) I questioned them about their high and low moments of the past eight months and any useful tips or experiences I could use in the time leading up to my move abroad and during the eight months at the affiliate.

When I was applying to the program the rotation system and in particular the eight months spent at an affiliate were among the main reasons I really wanted to be successful in obtaining one of the positions. Therefore I thought it might be useful to share some of the stories and insights Mark and Sascha told me; also because I know for some people being sent to a random country (and it is really any country as you have no influence over where you will be sent in the RA program) can be daunting.

Let me start by providing you with the basics about Sascha’s and Mark’s rotation. Sascha went to NNi, the affiliate in Princeton in the US also coined small headquarter in Novo Nordisk, and Mark to the production facility in Brazil. Mark had never been to Brazil before whereas Sascha had visited the US twice and even lived there for a short period of time. Thus they had very different rotations with diverging tasks, impressions and cultural experiences.

For Sascha his rotation at NNi was hist first exposure to RA work as he had spent the first rotation outside RA in the medical writing department. He focused on the future insulins and got to work on many different projects in numerous departments. The flexibility and wide exposure to different products were the features Sascha enjoyed the most and he ended up working with most of the diabetes portfolio in just one rotation. This is an experience many graduates make when spending time at an affiliate. The smaller workforce and the less rigid structures means your role will be far less defined and constrained.

In Mark’s case it was the opposite, after having spent 8 months in an RA department in Headquarters he joined the Quality Management Systems team in Brazil working with the implementation of such systems at the local site as well as with customer complaints and RA site approvals among other tasks.

Now let me get down to the nitty-gritty questions I posed them:

blog post 3-1

First Reaction?

I was able to emphasize greatly with Mark in this case as he had never even considered the possibility of going to Brazil. I had the same sensation when I was told that my rotation was in Vietnam. Sascha on the other hand stated that he was neutral about it and grew more and more excited as working in headquarters showed him the importance of NNi.

Biggest Fear?

Whereas Sascha worried mainly about his previously mentioned lack of RA experience and was not sure if he would be able to contribute anything of value; Mark’s main concern was focused on the ability to communicate. At least he believes it should have been his main fear but he might have been a bit naive about such issues before actually experiencing it first-hand.

blog post 3-2

Other Graduates at the same Affiliate?

Very surprisingly Sascha was the only graduate going to NNi at the time, very unusual as NNi is one of the prime destinations for graduates, and was joined later by finance graduates. Mark was accompanied by two Product Supply graduates for whom Brazil is one of few possible locations.

Social Life?

From a graduate perspective Mark was lucky as graduates have a special bond among them so going somewhere with other graduates immediately means you have a set of friends that have the same fears and ‘dreams’  as you. That does not mean that Mark only interacted with two people or that Sascha spent his rotation being lonely. Both found it easy to join in the social life with Mark participating in numerous sport teams and Sascha being surrounded by a group of very kind colleagues who took him in immediately.

blog post 3-3

Biggest Learning?

Both state the ‘affiliate view‘ as one of the main learnings that they are taking back to headquarters. It is very valuable to obtain an understanding of the differences between the local and the global needs. For Sascha his 8 months at NNi also provided him with an immense knowledge about the FDA which will be extremely useful in his further work in headquarter.

Moment of Struggle?

For Mark the lack of Portuguese skills did pose a problem at times and it can be frustrating when you feel unable to contribute as you are not able to grasp the whole problem due to communication issues. Nonetheless the graduate program is a lot about adaptation and pushing you outside your comfort zones; so be aware of such issues but do not let them demotivate you. On the other hand, Sascha did not even have one negative word to say about his 8 months in the US.

Now that I have completely exceeded our character limit and still feel I have so much more to say, I will leave you with a map of past destinations of RA graduates to give you a feeling of where one might end up. Please feel free to ask me questions in the comments.

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What does a Regulatory Affairs (RA) graduate actually do?

Category: R&D Global Development | (11) comments

Bring drugs to market’, stakeholder management’ and ‘strategic input

are probably some of the phrases the internet bible, that is google, flagged up during your search of what a RA professional does. How does that translate into what the daily activities of a RA professional are, I hear you cry? Well sit back, relax and make yourself comfy for at least the next few minutes, as I will attempt to give you an idea of what you are signing up for when you submit your application before the 8th Feb.

Before I continue I have a little confession to make, whilst I am a RA graduate my first rotation is actually within Chemistry, Manufacturing and Control (CMC) Supply. One of the many beauties of the graduate program is the rotational element; one of your 8 month rotations will be outside of RA, but in a department closely aligned to RA, which leads me nicely into my next paragraph…

CMC Supply

CMC supply is a pretty awesome place to work because:

A) One day you may go into work to see an ice cream machine in the coffee room, which signals you to start salivating like one of Pavlov’s dogs

B) Following the arrival of said ice cream machine, your department manager may tell you to ‘help yourself to as much ice-cream as you want’ (adios waistline)

C) CMC Supply is the heart of the formulation and development of our drug products. In a nutshell, we are the middle men and women between our research laboratories discovering a novel drug product that can kick the ass of diabetes (and other other chronic disorders), and our colleagues in product supply, who manufacture the drug on a commercial scale to then ship to patients across the globe.

Blog post 3 ice cream

This was no mirage, there was an ice-cream machine in my office!

Now I should really get on with telling you a little about what I actually do:

’Bring drugs to market’

Think less breaking bad and more Phase 3 drug development, with the latter being a pivotal stage in the ‘bring drugs to market’ concept. In Phase 3 you compile and submit all your documents to health authorities as part of a new drug application (NDA). The NDA essentially proves that you have the coolest drug product out there, bar none. Recently, I authored one of the first documents from our department to be submitted to the FDA as part of the NDA. Thus highlighting that you get real responsibility from the get go and a real chance to apply yourself. However, it must be noted that such a task could not be completed alone and I was able to get by with a little help from my friends -not Paul McCartney and Co, but my stakeholders.

‘Stakeholder management’

Whether I am relying on a chemist in my department to review a protocol  I am writing, to ensure it is scientifically viable or a colleague in analytical support to give me input on validated methods used to test the stability of our drug product; stakeholders and their input is key to your day-to-day work. Don’t be surprised if you can sometimes spend the best part of a day in meetings with your stakeholders or find yourself negotiating deadlines for their input. I am quickly learning that if you manage your stakeholders well, you have won half of the battle in finalising a task you are responsible for.

‘Strategic input’

Recently I tried my hand at being strategic during the writing of a protocol for a study that confirms our drug product is degraded in light and hence must be stored away from light. Sounds simple right? Well not so simple, as we need to decide on what stability indicating test parameters we want to investigate. To cut a long story short, I made a suggestion of not including some test parameters in the submission package as part of that NDA application I told you about earlier, but still testing said parameters and keeping them in house in case FDA has questions around them. Apparently, this is a good suggestion and considering up until now, the most strategic thing I had done involved me placing hotels on the orange property set of the monopoly board and bankrupting my whole family in the process (sorry guys), I think it is safe to say I am learning and reaching new strategic heights.

blog post 3 monpoly

It’s like looking in the mirror.

For me to be able to help in the process of bringing drugs to market, whilst managing various stakeholders and trying to give some strategic input from time to time I have been trained and continue to receive ample training to aid my development. Training will be the theme of my 4th blog post, so stay tuned folks :)

 

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