Return to the Transferable Skills for PhD Careers Index
Communication as a Associate Director, Regulatory Affairs in Regulatory and Clinical Affairs
Communication is key for Regulatory Affairs. I once talked my way out of having to initiate a recall with regulators. I convinced them that it wasn't necessary and had the data to prove it. This was all due to having effective communication skills.
- Basic writing and editing
- Oral communication skills
- Speaking clearly and effectively
- Written communication skills
Managing Up/Down as a Associate Director, Regulatory Affairs in Regulatory and Clinical Affairs
In regulatory, it is imperative to have the ability to manage up/down and sideways. There was a looming risk to have certain products registered in a particular country, I had to convince my boss and other executives that we had to proceed with the registration.
- Ability to manage others
- Dealing with conflict
- Negotiating difficult conversations
Strategic Thinking as a Associate Director, Regulatory Affairs in Regulatory and Clinical Affairs
- Ability to make decisions and solve problems
- Ability to set a vision and goals
- Creating vision and goals
- Creativity/innovative thinking
Communication as a Clinical Scientist in Regulatory and Clinical Affairs
Communication is a key part of clinical scientists. Half of the job is sitting in on meetings and influencing the team. The other half is communicating via email, publications, etc.
- Basic writing and editing
- Oral communication skills
- Presenting research to scientists
- Speaking clearly and effectively
- Writing scientific publications
- Written communication skills
Teamwork as a Clinical Scientist in Regulatory and Clinical Affairs
Clinical scientist is one role in a larger team. CS works closely with operations, regulatory affairs, medical writers, biostatisticians, etc.
- Ability to work on a team
- Ability to work with people outside the organization
- Contributing to institution (ie participating on committees)
- Providing constructive feedback
Managing Up/Down as a Clinical Scientist in Regulatory and Clinical Affairs
Clinical scientists work within larger organizations. Soft skills such as influencing both internal and external stakeholders are key to this role.
- Ability to manage others
- Dealing with conflict
- Negotiating difficult conversations
- Seeking advice from advisors and mentors
Strategic Thinking as a Clinical Scientist in Regulatory and Clinical Affairs
Clinical scientists may be involved in strategic thinking around how to best design a clinical trial; which indication to pursue for a particular molecule; how to best position the molecule for success.
- Ability to make decisions and solve problems
- Ability to set a vision and goals
- Creating vision and goals
- Creativity/innovative thinking
Integrity as a Clinical Scientist in Regulatory and Clinical Affairs
Clinical scientists design trials involving human patients, so integrity is key to every process.
- Can identify and address research misconduct
- Complying with rules and regulations
- Demonstrating responsible authorship and publication practices
- Demonstrating workplace etiquette
- Maintaining positive relationships with colleagues
- Upholding commitments and meeting deadlines
Project Management as a Clinical Scientist in Regulatory and Clinical Affairs
Clinical scientists are involved in the management of clinical trials.
- Ability to manage a project
- Delegating responsibilities
- Developing/managing budgets
- Managing data and resources
- Planning and organizing projects
- Providing instruction and guidance
- Time management
Interpreting Information as a Clinical Scientist in Regulatory and Clinical Affairs
A key role of the clinical scientist is to stay abreast of the scientific literature and competitive landscape; it is important to fully understand how this information affects the clinical development plan.
- Interpretation of data