At DiaMedica Therapeutics, we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of therapeutics. DiaMedica Therapeutics teams are creative, collaborative, open, committed–and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.
Please, no unsolicited resumes from recruiters.
Reporting to the Director of Clinical and Regulatory, the Regulatory & Clinical Trial Specialist executes the regulatory strategy in support of DiaMedica Therapeutics company objectives. Secondary to the regulatory function, this position may also support the planning and execution of clinical trials.
- Prepare, coordinate, and maintain global regulatory submissions, including Investigational New Drug Applications (IND) and New Drug Applications (NDA) to ensure timely approvals for clinical studies and market release
- Assist in the development of regulatory strategies to achieve company objectives
- Act as the primary company contact for regulatory agencies
- Prepare for and participate in meetings with regulatory agencies such as Food and Drug Administration (FDA) Pre-IND and Pre-NDA meetings
- Ensure that pre-clinical and clinical study designs meet regulatory requirements
- Maintain all regulatory files, ensuring documentation is complete, up to date, and audit ready
- Prepare for and participate in internal and regulatory agency audits
- Select and manage external vendors/consultants to ensure that deliverables are completed on time, within budget, and are consistent with the scope of work
- Monitor global regulatory changes and distribute information to key stakeholders
- Participate in departmental initiatives related to SOP development, training, or other projects
- Develop an understanding of competitive landscapes for assigned products and therapeutic areas
- Assist with the development of study related documents and materials such as protocols, study plans, informed consents, and recruitment materials
- Perform quality review of study documentation to ensure audit-readiness
- Support the development of clinical study reports
- Assist in the planning of investigator and coordinator meetings, Safety Review Committee meetings, or other meetings as required, including preparation of meeting materials
- Assist with vendor management
- BA/BS degree
- 2+ years of regulatory experience in a biopharmaceutical or medical device company
- Working knowledge of FDA regulations related to investigational drug/device applications and marketing approval
- Excellent interpersonal and communication skills (oral and written) with the ability to work independently and in a team environment
- Demonstrates good judgement and seeks the advice of others when necessary
- Strong analytical skills with high attention to detail and accuracy
- Strong organizational skills with the ability to problem-solve and manage multiple tasks
- Pharma/biotech experience
- IND/NDA experience
- RAPS Professional Certification (RAC)
- Working knowledge of Good Clinical Practices (GCP) and current industry practices related to the conduct of clinical trials
LOCATION: Plymouth, Minnesota
ABOUT DIAMEDICA THERAPEUTICS:
DiaMedica Therapeutics is a biopharmaceutical company focused on the discovery and development of novel therapeutic compounds that target deficits in microvascular circulation such as ischemic stroke and diabetic nephrology. DiaMedica's lead compound, DM199, is a clinical stage recombinant human protein that represents a novel biological approach to improving brain and kidney function and moving into phase II studies.
We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information, or any other protected category and to comply with applicable federal, state, and local regulations regarding discrimination in employment.
Send cover letter and resume to HR@diamedica.com.