Medical Compliance Manager

Niche Pharma company

HQ’d in Cambridge it is expected that role can be performed from home (after lockdown)

If you’re an experienced medical affairs / medical compliance professional who would like to know about a really broad, multifaceted role with a small, niche pharma company I’d love to hear from you to tell you about a role I’m handling.

My client is a science driven pharma bringing genuinely innovative products to a patient population with unmet needs.  Headquartered in Europe they’ve undertaken an ambitious and successful expansion strategy over the last 5 years and have a diverse and fascinating pipeline going forward.  While the company is niche and relatively small they come from a very well established and secure background as a business.

The existing, high calibre, medical team is small and are covering all aspects of medical affairs; we’re looking for someone who can help build on what is already a proven and value-added function.

The role we’re recruiting for is broad and is centred on medical compliance with some additional interesting aligned functional responsibility.  Specifically, we’re looking for someone who can cover GDP compliance in the capacity of a local RP as well as covering local PV activities.  While GDP and PV are managed globally our client is looking for someone who can take point at a UK level.

In an ideal world the person taking this role will also be able to act as a medical final signatory though this is not a pre-requisite.  For people who are qualified to act in this capacity training can be offered to achieve final signatory status.  It’s really important to note that while the final sig training can be offer, I regret that this role is not open to aspirants to industry.  A solid background in medical information including copy approval is an absolute requirement here.

So in summary the role would include:

All aspects of medical information service provision including 1^st and escalated enquiry handling, reference checking, literature review and copy approval.

Acting as the local lead for medical / healthcare / ABPI compliance.  This will include developing and maintaining the existing medical compliance framework including SOP writing, managing complaints and building and leading training internally around medical compliance.

Acting as the Responsible Person (RP) for GDP compliance purposes expected to be c20% of the role overall.

And ideally acting as final signatory though this is not a requirement and training can be offered for final sig capable people if they have existing expertise in med info / med affairs.

The person we’re looking for;

An experienced medical affairs professional with a successful track record in the discipline gained over a number of years. I’m looking for someone who’s covered the full span of medical compliance activities and can take overall responsibility for the function.

Someone with a really firm grasp of medical compliance requirements who can not only define what needs to be done but can effectively work with people to drive a fantastic compliance culture.

Someone happy to take on non-promotional activities that might not normally be considered core to medical affairs / medical compliance. A good example of this would be the RP duties.  The existing team relish the opportunity to engage in tasks and projects that fall outside of the typical bounds of medical affairs.  We’re looking for someone who’d be equally keen to roll up their sleeves and get stuck into novel projects.

What my client offers is the opportunity to work with a team you’ll love. I know both people in the medical team here and hold them in the highest esteem both from a professional and interpersonal perspective.

You’ll also be working for a really small, successful and still developing company. No two days will be the same and you’ll have the opportunity to bring a lot of your own ideas and projects to the table.  This role would really suit someone who wants to work in a role that has a mixture of operational, project and strategic responsibilities.

The difference this company is making can’t be understated. The patients benefiting from their products are really underserved and you’d be helping change their lives and those of their families.