9 дней назад
Externally Sponsored Research Manager (Biopharma)
100 500 - 145 166$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Externally Sponsored Research Manager (Biopharma): Managing externally sponsored research studies from proposal submission through closeout with an accent on scientific review coordination, regulatory compliance, contracting, product supply, and milestone tracking. Focus on maintaining study data integrity, supporting audit readiness, coordinating cross-functional stakeholders, and improving research program analytics.
Location: Morristown, New Jersey, United States; onsite. Applicants must be residents of the United States or Puerto Rico.
Salary: $100,500–$145,166.66 per year, commensurate with experience.
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines for immune challenges, rare diseases, blood disorders, cancers, and neurological disorders.
What you will do
- Manage externally sponsored research operations from unsolicited proposal submission through study closeout.
- Coordinate Scientific Review Committee activities, study reviews, agreements, regulatory documentation, product supply, purchase orders, payments, and milestone tracking.
- Ensure ESR processes follow company procedures, applicable laws, regulations, and compliance standards, supporting audit readiness.
- Maintain study records, data integrity, access controls, permissions, reporting, KPIs, and business analytics.
- Collaborate with Product Supply, contract manufacturers, systems teams, vendors, and cross-functional stakeholders to resolve issues and deliver study requirements.
- Support safety updates, Dear Investigator Letters, system training, and access for ESR stakeholders.
Requirements
- Bachelor’s degree in life sciences or a related scientific discipline.
- At least 2 years of relevant experience in clinical operations, hospital settings, pharmaceuticals, or another regulated medical environment.
- Familiarity with Investigator Sponsored Studies, GCP, ICH standards, compliance codes, and the external regulatory environment.
- Strong quantitative, analytical, problem-solving, verbal, and written communication skills.
- Experience managing diverse stakeholders and collaborating across functions and seniority levels.
- Ability to anticipate obstacles, drive process efficiency, and work independently with minimal direction.
Nice to have
- Project management experience or certification such as PMP.
Culture & Benefits
- Supportive, future-focused environment centered on scientific innovation and patient impact.
- Opportunities for promotion, lateral development, and international career growth.
- Healthcare, prevention, wellness, and other employee benefits.
- At least 14 weeks of gender-neutral parental leave.
- Work with AI, data, and digital platforms in drug discovery and development.
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