Regulatory Affairs Associate Job

REGULATORY AFFAIRS ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in COLLEGEVILLE, PA AREA.

WHAT YOU'LL BE DOING:

- Accountable for applying new processes and strategies to assigned tasks or activities; may also contribute to identification of issues and propose ideas to manage risks to timelines, budgets and goals.
- Independently executes/delivers assigned study or program level tasks or activities within framework of the broader study/program
- As appropriate, may contribute to scientific plans, documents, or processes for one or more studies.
- With oversight, may co-lead and manage operational or scientific project work
- Interacts with internal stakeholders.
- Supports or oversees one or more local or global studies
- With limited oversight may co-lead and manage project work OR may independently execute assigned study tasks or activities.
- Deliver their assigned task or activities within framework of the broader study/program
- Contributes to or leads study team(s) to ensure successful local or global study delivery per agreed quality and timelines
- Contributes to the development of study and project strategies as appropriate.
- Understands the implications of decisions made by study/project team and proactively identifies study and project risks where appropriate; seeks to mitigate risks where appropriate.
- Demonstrates effective team working in a Matrix environment; actively promotes team work within project. Understands and values the contributions of others within Matrix team.
- Demonstrated ability to seek and understand different perspectives, developing alternative solutions and valuing options suggested by others within project.
- Proactively generates ideas for improvements and takes actions to solve problems and achieve team goals.
- Increasing ability to identify and clarify problems, recommend creative solutions and influence appropriate changes.
- Demonstrates understanding of internal and external customer requirements and proactively takes steps to improve deliverables.
- Demonstrated effectiveness in communicating both internally and externally with tact and diplomacy.
- Demonstrates an ability to contribute to and effectively influence individuals, objectives and accomplishments in a Matrix team environment.
- Ability to understand and clarify boundaries of responsibility within own role; allocates decision-making authority and task responsibilities to other team members as appropriate.
- Uses appropriate interpersonal styles and communication methods to gain acceptance of an idea.

WHAT YOU NEED TO BRING TO THE TABLE:

- Pharmaceutical and/or clinical trial experience - minimum of five (5) years
- Minimum of a BA/BS degree is required
- Experience within or knowledge of the expected assigned therapeutic area.
- Experience drafting assigned sections of key clinical documentation, eg protocols, study reports and dossiers.
- Experience coordinating clinical sections of regulatory documents such as Investigational New Drug (INDs) and New Drug Applications (NDAs)
- requires scientific qualification undergraduate degree or equivalent in a science or health related discipline
- Broad experience in Clinical development or equivalent experience in the pharmaceutical or health-related field
- Demonstrates relevant drug development experience within the Pharmaceutical industry
- Some related or direct experience in work either or within industry
- Basic or broad knowledge and experience in clinical development; may have direct experience in assigned therapeutic area

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayCLINICAL

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