Scientist (Cary, NC)
Allucent
Cary, north carolina
Job Details
Full-time
Full Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Scientist (Fellow) to join our A-team (hybrid). As a Scientist (Fellow) at Allucent, you are responsible for assisting with writing, evaluating, and assembling technical documents in support of regulatory, clinical, chemistry manufacturing and control (CMC), or non-clinical sections of regulatory submissions. The Scientist develops further knowledge of Health Authority (HA) Guidances and Regulations, pharmaceutical development, CMC, clinical, and non-clinical principles. The Scientist will serve on project teams in various capacities, including but not limited to, Scientist or, Medical Writer, as well as assisting the Project Lead..
In this role your key tasks will include:
- Assists with the review, writes, or co-writes regulatory, clinical, CMC, non-clinical and scientific documents and reports, or sections thereof, with guidance from more experienced Allucent personnel
- Contributes to strategic/analytical discussions regarding drug, biologic, or device development issues
- Develops further scientific knowledge of HA regulatory guidance and regulations in areas of expertise (i.e., clinical, non-clinical, CMC, regulatory)
- Further develops competency in electronic common technical document (eCTD) format and requirements of regulatory submissions
- With guidance, assists in interactions with various HAs such as meeting and briefing documents and responses
- Further develops knowledge of product development plans and/or strategies from early development through Phase 4
- Participates in meetings with clients
- Performs other scientist- or project-related duties, as assigned
- Performs work as instructed when given detailed or general instructions on assignments
- Contribute to other areas of business as required
Requirements
To be successful you will possess:
- PhD or equivalent degree in a scientific area and/or relevant experience
- ≤ 1 years’ relevant industry experience
- Demonstrated critical thinking and analytical skills
- Strong written and verbal communication skills in English
- Computer skills, including Word, Excel, and PowerPoint
- Builds working relationships internally
- Thinks ahead for potential opportunities and challenges
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-TR1 #LI-Hybrid