About Dawn Heimer:
Skilled at strategic planning, due diligence, and managing teams to attain peak potential and engagement. Absorb and analyze information to help teams make better decisions. Possess a growth mindset and motivated by solving complex problems under tight timelines and in compliance, which are critical to organizations’ reputations and the ability to drive business objectives to completion. Dedicated to continuous improvement and thriving when managing critical / crisis situations. Adept at problem-solving in the moment and anticipating issues to apply preemptive solutions. Reliably deliver quality clinical data for regulatory and marketing purposes.
Experience
OLYMPUS CORPORATION OF THE AMERICAS - Vice President, Global Head of Clinical Affairs
Owned all aspects of clinical study operations, strategy, and planning for > 50 projects worldwide with > 35 US, EU, and Japanese staff members with budget > $14M. Gained alignment from FDA and guided cross-functional team through root-cause analysis and study restart plan for business-critical, 522 Postmarket Surveillance Study.
BECTON DICKINSON (BD)
Senior Director, Clinical Affairs, Interventional Surgery
Inspired associates to maximize engagement in projects and expand individual talents to accelerate timelines. Managed global clinical affairs strategy for products in hernia repair, breast reconstruction, and surgical hemostasis, including new business development and Post-Market Clinical Follow Up (PMCF) studies for compliance with European Union Medical Device Regulation (EU MDR).
C.R. BARD
Director, Clinical Affairs, Davol
Set department vision and mission. Built and maintained clinical affairs function in support of product development, maintenance of business continuity (e.g., problem-solving of manufacturing issues), and business objectives, including budget/contract/vendor management, and L&A activities. Grew and maintained strong internal and external relationships / partnerships through acquisition by and integration with BD.
JOHNSON & JOHNSON, INC. (J&J)
Manager, Clinical Research, Advanced Technologies and Regenerative Medicine
Led drug, device, and biologic clinical research in US, EU, Asia and Australia that included CRO/vendor management, strategic plans for reimbursement. Managed 11 full-time and contract resources across 3 J&J operating companies. Managed and forecasted departmental budget of $6M+. Created and implemented CAPAs (corrective and preventive action plans). Authored clinical content for IND, IDE, and 510k applications and verbal and written communications to FDA.
Education
- Doctor of Philosophy (PhD), Behavioral Genetics, University of Connecticut, Storrs, CT
- Master of Science (MS), Developmental Psychobiology, University of Connecticut, Storrs, CT
- Bachelor of Science (BS), Biology with a minor in Chemistry, Niagara University, Lewiston, NY
- Bachelor of Arts (BA), Psychology, Niagara University, Lewiston, NY
Professionals in the same Pharmaceutical / Bio-tech sector as Dawn Heimer
Professionals from different sectors near Exeter, Town of Exeter, Washington
Other users who are called Dawn
Jobs near Exeter, Town of Exeter, Washington
-
RIA Consultant
Found in: Jooble US O L C2 - 15 hours ago
Fidelity Investments Providence, RI, United StatesFinancial Consultant · If you no longer want to spend your time on sourcing new clients and would rather have the time to deepen relationships and create complex financial plans, then join a team that is a stable industry leader. Fidelity provides a business model with an existi ...
-
Production Manager
Found in: ZipRecruiter Test10S US C2 - 19 hours ago
Manufacturing llc Providence, United StatesJob Description · Job DescriptionBenefits:401(k) · Competitive salary · Opportunity for advancement · Training & development · As the Shift Manager, you will lead our operations departments, overseeing the integration of production, packaging, sanitation, and maintenance activiti ...
-
Bookkeeper
Found in: One Red Cent US C2 - 1 week ago
Financial Innovations Cranston, United StatesExperienced Bookkeeper wanted for a busy promotional products distributor in Cranston, RI. · 35-40 hours/week required. · Main Duties: · Maintain the QuickBooks database · Maintain Accounts Receivable/Payable · Create Commission and Royalty Reports · Billing/Invoicing · Collecti ...