Job Description- Ascendis Pharma / KGI Good Clinical Practices (GCP) and Pharmacovigilance (PV) Regulatory Compliance PharmD Fellowship
|Full name||Recruiting in process|
|Job Title||KGI PharmD Fellow- 2-year fellowship|
|Job Location||United States|
|Name / Title of Ascendis Pharma Manager||Eve Kwan / Senior Director, GCP and PV Regulatory Compliance|
Ascendis Pharma is a dynamic, growing biopharma company with offices in Denmark, Germany and the United States. Ascendis Pharma is advancing programs both in endocrinology, where we have three rare disease product candidates in clinical development, and in oncology, where we are building a pipeline of candidates.
Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to supporting your professional development on our journey.
To learn more about us, please visit us at https://ascendispharma.com/
Education and Experience
A successful candidate must be a PharmD graduate from an ACPE accredited institution. All candidates must have the right to work in the USA. The fellowship will provide comprehensive practical hands-on biopharmaceutical training and foster an environment of learning with a biopharmaceutical company. The fellow will be paired with leaders in the GCP and PV Regulatory Compliance functional area. The collaborative environment will offer the fellow an enduring network and exposure to grow exceptional skills.
-This individual will support Quality Assurance initiatives in the GCP/PV areas to ensure that the appropriate processes, systems, and activities are in place to protect the rights, safety, and welfare of clinical patients
-Participating as Quality Assurance oversight on Study teams for Ascendis’ endocrinology/oncology programs
-Provide support in assessing audit or regulatory inspection observations
-Leading Business Continuity Planning initiatives for Development Operations, Clinical Development, Pharmacovigilance, and Compliance
-Setting up Quality agreements with third party contracts, such as Contract Research Organizations, Central Lab vendors etc.
-Support the overall operations of the compliance team by participating in process improvement initiatives, tracking, and reporting key operational metrics, and ensuring audit readiness.
-Support and coordinate activities, information, and resources with other personnel including taking minutes at meetings to allow dissemination.
-Strong work ethic and sense of adaptability. Candidate must demonstrate ability to take direction and work both independently and as part of a team.
-Pro-active approach to assigned responsibilities, with responsiveness to prioritize according to needs of the project.
-Reliability, strong attention to detail, accuracy and effective organizational skills in planning and overseeing multiple parallel long-term projects.
-Experience with gathering, processing, analyzing and critically evaluating data.
-Commitment to communicating respectfully and effectively within the team.
-Strong written and communication skills.
-Project management skills are a plus
Application Process: This is a 2 year fellowship
Candidates must submit all the following application materials to
KGI Fellowship Director Prof. Bernard Tyrrell (Bernard_tyrrell@kgi.edu.)
Office phone 909-607-0447.
We will be accepting applications from Monday May 10 to May 28, 2021.
Applications materials need to include the following:
- Letter of Intent.
- Updated curriculum vitae (CV).
- One letter of recommendation emailed directly from letter writer to Fellowship Director.
- Unofficial pharmacy school transcripts emailed to Fellowship Director.