Fellowships

This two-year fellowship in biomanufacturing is a collaboration of with Curia Global, the FDA Office of Pharmaceutical Manufacturing Assessment (OPMA) and Albany College of Pharmacy and Health Sciences. 

The partnership of a global pharmaceutical company with a regulatory agency and an academic institution provides a rich and rewarding experience for the fellow. In addition, the three partners build on their individual strengths and common objectives to create compelling projects over the two-year span.

The fellowship is ideal for a PharmD and/or PhD holder who is interested in working in a dynamic environment with diverse cross-functional teams.

To learn more, please visit Curia Global.

The FDA Office of Pharmaceutical Manufacturing Assessment (OPMA) assures that quality pharmaceuticals are consistently manufactured over the product lifecycle. For more information, please visit the FDA Office of Pharmaceutical Manufacturing Assessment (OPMA).

Deadlines:

• The dates for submitting applications will be listed prior to the new search starting

This fellowship will provide real-world experience and exposure to various functional areas within a Medical Affairs Department, encompassing training, medical information, and medical communications, during a two-year US Medical Affairs Fellowship Program at Ascendis Pharma, focusing on rare disease endocrinology.

This hybrid position is based in Princeton, NJ. This role is required to be on-site at least two days per week.

Major Duties & Responsibilities:

First-Year Learning Objectives:

• Obtain a comprehensive training within our disease states and products and/or investigational agent
• Develop scientific content for internal and external educational needs within Training and Medical Information, inclusive of field resources and scientific response letters.
• Research and anchor scientific content and participate in their review through the Medical and Promotional Review Committee process.
• Learn how to identify resource opportunities and evaluate vendor capabilities, including vendor selection, budget planning and project management.
• Experience and participate in product launch preparation to fulfill a business strategy.
• Assist with onboarding and knowledge advancement activities for both field and internal Medical Affairs team members

Second-Year Learning Objectives:

• Participate in planning and project pull-though for Training and other initiatives targeting Regional Medical Scientists (RMS/Medical Science Liaison -MSL) activities.
• Assess medical information inquiries and write standard response letters.
• Attend one congress, participate in booth coverage, and review response metrics.
• Achieve a thorough understanding of good publication planning process, while gaining knowledge in the tactical execution of publications, including collaborating with external authors on abstracts, poster presentations, and slides for platform presentations, as well as the preparation of papers for journal publications.
• Provide medical writing and editorial support for the scientific publication development process.
• Create a self-directed publication or poster and present it at a professional meeting.
• Describe the operational aspects of clinical trial design from startup, through execution, and closeout.

Education and Experience:

• PharmD degree from an ACPE accredited institution is required.

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills, ethics, professionalism, and leadership qualities
• Strong passion for science with an interest in the biopharmaceutical industry
• Excellent time management skills with the ability to observe schedules and meet assignment deadlines
• Demonstrates a positive work ethic
• Demonstrates the ability to work both independently and collaboratively

The Innovate in Pharmacovigilance Fellowship is a post‐graduate training program designed to train pharmacists in pharmacovigilance, with research and field‐based medication safety learning opportunities. The program provides two (2) year fellowships. 

A new approach to pharmacovigilance training, it launched in 2021 as a collaboration between pharmacists, safety scientists and data scientists from academia, industry and the US Food and Drug Administration (FDA). The fellowship distributes training activities over a two‐year period including 12 months at a life sciences company; four months at ACPHS; and eight months at the FDA.

Designed to build on a pharmacist’s core knowledge, the fellowship emphasizes three main areas of intensive training and competency development:

• Pharmacovigilance
• Medication safety
• Data science

Typical activities include safety surveillance and adverse event reporting, monitoring safety and quality of patient care and medication use systems, and analysis of the FDA’s adverse event reporting system (FAERS) data.

To learn more, please visit BeiGene.

The Crinetics Quality Assurance (QA) Fellowship provides two (2) years of comprehensive practical hands-on biopharmaceutical training and fosters an environment of learning within a fast-growing biopharmaceutical company.

The fellow pairs with QA leaders to support initiatives, provide QA oversight for various clinical trials and study teams, and work cross-functionally with all departments. The collaborative environment offers the fellow an enduring network and exposure to all aspects of the drug development process.

Learning Objectives:

• Support and participate in GxP activities
• Develop tools for tracking key performance indicators, create charting of KPI metrics, and collect KPI data from records and the QA team.
• Track status and progress of the Annual Audit Schedule ensuring that audit deliverables are completed in a timely manner.
• Ensure accurate filing of GxP audit records, investigation reports, associated corrective and preventive actions (CAPAs), and deviations.  
• Assist in GxP Inspection Readiness Activities including the tracking and scheduling of Story Board development and reviews.
• Work with QA team to identify enhancements to Vendor tracker, Approved Vendor List, and other tracking tools.
• Assist Document Control with formatting, preparation and review of controlled procedures within the EDMS.
• Work collaboratively with QA team to identify business processes and areas that require improvement and implement appropriate methods and tools to increase efficiencies.
• Support EDMS System Administrator with user testing of system configuration changes.

Application Materials:

• Letter of Intent
• Two (2) letters of recommendation (LOR) submitted via email directly from each reference.
• Curriculum Vitae (CV)
• Unofficial pharmacy school transcripts
• Any additional materials that the candidate feels would be useful to the interview committee may be submitted.

Deadlines:

• The dates for submitting applications will be listed prior to the new search starting.
• Interviews will be conducted on a rolling basis upon application review. Early application submission is highly encouraged. All rounds of interviews will be conducted virtually.