Requirements
- Bachelor's degree or higher is mandatory
- At least 10 years of professional experience in the pharmaceutical or scientific field required
- Minimum of 8 years focused on clinical or regulatory medical writing
- Demonstrated experience in managing projects and improving processes
- Minimum of 2 years leading and supervising staff
- Capable of independently interpreting, summarizing, and presenting complex medical and statistical data with precision
- Able to independently identify and resolve complex scientific and regulatory challenges
- Thorough understanding and application of regulatory standards, including ICH guidelines
- Engages effectively with senior-level internal and external stakeholders across multiple functions
- Proactively detects risks and formulates mitigation strategies
- Addresses and resolves issues tied to the creation and rollout of new services or deliverables
- Serves as a bridge between team members and senior leadership within a therapeutic area
- Exceptional verbal and written communication abilities
- High level of accuracy and attention to detail
- Advanced time management skills for self and team members
- Skilled at building and sustaining productive working relationships across departments
- Expertise in project and process leadership with strong organizational oversight
- Demonstrates strong leadership competencies including influence, negotiation, initiative, conflict resolution, and change management
- Delegates tasks effectively to junior writing staff
- Leads through example, maintains focus and positivity, and upholds ethical standards
- Understands and promotes CREDO values in daily work and mentorship
- Acts as a driver of change and adapts quickly to evolving business and organizational demands
- Proficient in managing people with a focus on performance and development
Nice to Have
- Analytics and insights generation
- Business communication and writing
- Clinical research and regulatory knowledge
- Clinical trial operations experience
- Copy editing proficiency
- Collaboration across functions
- Mentoring and developing team members
- Inclusive leadership practices
- Analysis of industry trends
- Leadership in matrixed environments
- Medical affairs engagement
- Medical communications expertise
- Performance tracking and reporting
- Quality assurance and validation processes
- Standard operating procedure (SOP) familiarity
- Succession planning experience
- Tactical planning skills
- Team leadership and supervision
