Secteur d'activité : Pharmaceutique
Job Title: Regulatory Affairs Assistant - II
Durée : 6 mois [+ Possibilités de prolongation]
Emplacement : À distance
Échelle salariale - 35 $ à 40 $/heure
Rôles et responsabilités du poste :
- Perform data entry, RIM System to enter relevant information to support key CMC RA stakeholders.
- Work collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory assessment comments.
- Ensure completeness, correctness and consistency of data.
- Responsible for acquisition of required system skills and knowledge; training supported by manager and peers.
- Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals.
Connaissances et compétences:
- Doit être familier avec la saisie de données dans des systèmes d'information complexes.
- Should have experience with Vaults, experience with the RIM Vault.
- Strong verbal and written communication skills and interpersonal skills.
- Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
- Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
Scientific background preferred.
- Biologics experience is a plus
Required Years of Experience: At least 2 – 3 years of experience
- Top 3 Required Skill Sets: Familiarity with data entry into complex information systems; strong verbal and written communication skills; experience with Vault, including RIM
- Top 3 Nice to Have Skill Sets: Basic understanding of Regulatory Affairs; scientific background preferred; biologics experience is a plus
- Unique Selling Point of this role: This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.
- Required Degree or Certification B.S. preferred