Work Placement / Internship

Student Placement - Regulatory Affairs Operations Associate

Start Date: Summer 2021

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We offer exciting 12-month placement opportunities to students that are looking to work with us to deliver on our mission to save and improve lives. A placement with us will give you the opportunity to collaborate alongside subject matter experts, bring your own ideas and share real responsibility whilst delivering on meaningful projects alongside a passionate, diverse and inclusive workforce.

This role will be based in our brand new, state-of-the-art co-working facilities in Moorgate, London; with fantastic amenities and support services including a gym, coffee bar and conference rooms.

Hear what some of our previous students and graduates have to say about their experiences on our programmes

"If you’re considering doing a placement year with MSD, I’d say go for it, I think it’s the best thing I’ve ever done!"

Who we are…

We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With over 70,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of over 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification for the third year running.

Job Description:

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organised compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

This Early Talent Student Rotation Assignment will work within our Company’s Global Regulatory Affairs and Clinical Safety (GRACS) organisation, in the Regulatory Affairs Operations - Europe, Middle East and Africa (RAO-EMEA) department. We are a diverse, dynamic team who provide an opportunity to develop a career in regulatory operations and play a key role in ensuring patients have access to our products which positively impact human life.

It will entail three rotations through the Regulatory Submission Planning, Publishing, and Health Registration Management (HRM) teams.

The Regulatory Submissions Planning and Publishing team assist with the planning and project management of regulatory submission development, assembly, and release to the country subsidiary or direct to health authority. The HRM team assist with the data entry into the HRM database, used to track the company’s registration information, which supports product release, compliance activities, and pharmacovigilance obligations.

Duties

Regulatory Submission Planning:

  • Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities
  • Developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones
  • Participate in Submission Planning Management Team (SPMT) meetings
  • Drive the submission assembly and delivery process with the Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines
  • Accessing and maintaining the regulatory systems and databases to fulfil daily functions.

Regulatory Submission Publishing:

  • Identifying and maintaining specifications supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organisation in the region
  • The publisher will assist with the maintenance of related processes in accordance with regional/country specifications, and also will assist the central publishing team who are accountable for executing the assembly processes to generate regional/country compliant to regulatory specifications
  • The publisher will execute the assembly and delivery processes, in particular to meet critical submission targets. The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions and transmission (e.g. agency gateways), dossier repositories and databases
  • Maintain the regional/country regulatory dossier assembly specifications (structure, organisation, formats: paper and electronic, delivery methods, etc.)

Health Registration Management:

  • Assist in regional procedures to ensure HRM data entry is compliant
  • Assist in the identification and resolution of data-entry- related errors within the specified region
  • Assist, and at times lead, efforts surrounding HRM metrics within the region
  • Assist in the implementation of HRM data quality strategies in the region and support users in the execution of the strategy at the country level
  • Develop standard responses for common queries which can then be used as “mini refreshers” for the HRM Community of Practice meetings.

Technical Specifications

  • You will be looking to complete a 12-month placement in your third or penultimate year of study, returning to your STEM degree course at the end of the placement
  • Demonstrates analytical ability
  • Technical specifications are flexible, but an affinity for and capability to learn Regulatory Information Management systems to execute operational tasks will be a significant asset.

Qualities we look for

  • Operates with a high level of integrity, transparency and accountability
  • Comprehends and aligns with our organisation’s core values
  • Aligns and fosters a culture of diversity and inclusivity
  • Demonstrates initiative, proactivity and academic curiosity
  • Encourages and boosts their colleagues through teamwork
  • Demonstrates clear and effective communication
  • Ability to build relationships with various stake holders
  • Demonstrates a desire to learn and improve their performance through feedback
  • Demonstrates ability to prioritise multiple tasks and work under tight deadlines.

Start Date

Summer 2021

How to apply:

Please complete the online application form and attach an editable CV and cover letter (not a PDF, please submit the CV and cover letter as 1 document).

In your cover letter we would encourage you to answer the following questions; Why are you applying to our company and why are you applying for this role?

Additionally, you may include any additional information you feel further supports your application.

Maximum word count for your cover letter: 300 – 400 words. Please do not exceed this.

Our recruitment process for this role is: An online application, an online assessment, a telephone interview and then a final virtual assessment.

Deadline for applications:

We assess applications on a rolling basis, so we encourage you to apply as soon as possible. This role will be removed once this position has been filled.

Other important information:

Our presence in the UK goes back a long way. For over 80 years, we’ve been researching, developing and supplying new medicines and vaccines that prevent and treat diseases that occur at every stage of life.

Today we're one of the top five biopharmaceutical companies in the UK and employ over 2,000 people across five sites in Hertfordshire, Northumberland, Buckinghamshire, Edinburgh and London.

How are we adjusting our hiring process with COVID-19?

Our key priorities during the current COVID-19 outbreak are both maintaining supply of critical medicines to our patients and ensuring the health and safety of our employees and candidates. In support of Government measures to limit the spread of infection, we have therefore developed a new flexible, virtual route for candidates applying and interviewing for our open roles.

Equal Opportunities

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

What we look for…

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organisation. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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Opportunity Overview

  • Ongoing
  • Competitive + benefits
  • All grades
  • Year-long
  • London
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Disciplines accepted...

  • All STEM disciplines

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