Job Description
• Provide scientific and strategic input across various stages of clinical development to achieve market approval for new products and/or novel indications.
• a. Duties performed as a member of a cross-functional team of internal and external experts and in support of the clinical director.
• b. Projects are focused on medical devices, drugs, biologics, and/or other products for human use.
• c. Projects may span from in-development to post-marketing studies and products.
• Coordinate and integrate data and information from a variety of sources (e.g., internal and external studies, research documentation, and published literature) to support various clinical development initiatives.
• Consolidate input from internal and external contributors to develop appropriate key messaging.
• Support early-phase development activities, including curation, review, and interpretation of preclinical, exploratory data.
• Provide scientific guidance and technical expertise within teams, across departments, and across functions by providing strategic, actionable direction, creating a strong sense of team unity and identity, and providing positive, constructive feedback.
• Identify and troubleshoot study-specific issues, competing priorities, and clinical or scientific challenges.
• Ensure effective, accurate, and timely communication of key issues and progress to the team and senior management.
• Support planning and preparation for internal and external stakeholder meetings (e.g., workshops/summits, investigator meetings, scientific advisory boards, and regulatory meetings)
• Write, review, edit, and approve high-quality and timely clinical documents, contributing scientific/technical expertise related to clinical development and document preparation.
• Demonstrate understanding and interpretation of data generated from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer-reviewed literature and provide meaningful scientific interpretation and feedback to team members and other stakeholders.
• Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plans.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• Masters Degree in Life Sciences
• Understanding of clinical product development, clinical trials, and global regulatory submissions
• Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155
• Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables
• Readily adaptable to changes in priorities
• Demonstration of excellent verbal and written English, including understanding of English language usage in clinical/technical environments and standardized-writing styles.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.