We met with Claire Holmes, Associate Director of EU Regulatory Operations for Accenture Applied Life Sciences Solutions. She oversees European regulatory operations projects to ensure client obligations and contract requirements are met. She also works as an Accenture performance achievement strength coach. Her breadth of experience in Life Sciences has given her a unique perspective and empowered her to know her own strengths. Here’s what she had to say:
On her biggest achievement.
CLAIRE HOLMES: I joined the European Medicines Agency, EMA, and was a program manager affiliated to the regulatory affairs unit. I worked with the Network of European Competent Authorities and I worked with pharmaceutical companies and trade associations, looking at the implementation of new directives, regulations, legislative guidelines coming from the European Commission.
There was a revision to the clinical trials directive in 2001, primarily around implementing a single European portal for clinical trials application management. I produced an EMA impact assessment for the European Commission proposal for the revision of the clinical trials legislation, looking at what the impact of that would be on pharmaceutical companies, on all stakeholders.
My biggest achievement was leading the successful project to implement the eCTD for the centralized procedure in Europe. I was ensuring that the agency’s e-submission program was steered forward consistently, often in the face of really complex stakeholder relationships, conflicting requirements. There were many conflicting requirements between EMA and the rest of the European Continental Authority network.
On how she made it happen.
CH: I think it was my personal initiative and leadership that ensured that the agency published its statement of intent. I remember driving very hard for that, saying nobody is going to do anything, we’re going to be forever just stuck if we just say we are going to do something but if we don’t publicly commit to it.
On adding a personal touch to her work.
CH: The EMA had a reputation as being sort of notoriously impenetrable, and not very collaborative, and I wanted to change that. I felt very strongly that we needed to collaborate with our other stakeholders, with pharmaceutical companies who were going to be the primary people affected by, impacted by these changes, and the legislative changes. And we also needed their expertise and their input. They were absolutely invaluable. So, we formed a joint program committee and I worked very closely with a number of people from pharmaceutical companies to develop the practical guidance for eCTD.
On being naturally collaborative.
CH: Being known and having that reputation as somebody who was collaborative and open and facilitative, helped my professional life because I wouldn’t have joined Accenture otherwise.
It also helped me immeasurably from a personal perspective in understanding what my strengths are and where I can make the greatest impact. I’ve come to understand that I am a highly collaborative person. I want to bring as many voices into the conversation as possible. I believe that you have the highest chance of finding common ground and developing shared objectives by which everybody is motivated and where everyone feels responsible and accountable, and shared objectives that are inspiring for everyone. It’s my natural approach, and it applies to all areas of my life, not only my professional life.
On the importance of mentoring young women in Life Sciences.
CH: I believe passionately that we are all different and that there is value in our uniqueness. I want to help other people understand their strengths and their unique approach to leadership and management. I want people to understand their talents, be proud of their strengths, and gain awareness and insight into who they are. I want people to understand what motivates them, the value that they bring, and feel confident with the power they bring by being different.
This blog is part of a series that focuses on individual journeys of the women in life sciences who are driving change to how we develop and deliver better patient outcomes.