Regulatory Manager Resume Samples

Description :

1. Responsible for overseeing Adult Hematology & Oncology regulatory staff and 160+ protocols, in order to ensure all deadlines and trial initiation requirements are met.
2. Managed all Investigator-Initiated Phase I Trials.
3. Collaborated with Protocol Writer to ensure IIT protocol development is complete and compliant, with special attention to eligibility, study management, and safety reporting sections.
4. Ensured consent document financial information matches local Medicare Coverage Analysis.
5. Submited Initial IND Application and Annual Reports, the latter complete with adverse event information for participants to date.
6. Managed quality assurance measures to ensure safety reporting is complete and fully documented for monthly DSMC meetings.
7. Organized internal Site Initiation Visits for IITs, including slide preparation and training documentation.

Experience

7-10 Years

Level

Management

Education

Bachelor Of Science

Description :

1. Supervise all staff members in the patient care setting.
2. Responsible for hiring, evaluation, discipline and firing.
3. Supported budget and contract negotiation with investigational sites, as applicable, at their assigned sites; ensures payment for services.
4. Ensured recruitment strategies in place to meet study needs, including patient enrollment targets at their assigned sites.
5. Managed existing sites and develops new clinical investigator sites to meet Sponsor projected patient recruitment needs.
6. Monitored site quality and performance (metrics).
7. Developed solutions to optimize performance.

Experience

2-5 Years

Level

Executive

Education

M.B.A. In Corporate Finance

Description :

1. Served as the UBO system matter expert on all issues surrounding charging, billing and collections Provided feedback to management (including the HIM Directors, Chief Financial Officers & Hospital Admissions) and facilities on insurance verification and admission errors.
2. Reviewed unbilled reports and followed up with facilities' and HIM Director's to resolve.
3. Monitored claim submission error reports from HMS billing module, third party clearinghouse and on-line insurance tools.
4. Managed accounts receivables.
5. Assigned/allocated resources as required to ensure company goals for aging and accounts receivable days are met.
6. Identified and reported accounts receivable trends to management Ensured that all new/updated Medicare & private insurance reimbursement codes are made available to billers & collectors and updated on applicable UBO software.
7. Ensured Medicare bad debt logs were maintained.

Experience

10+ Years

Level

Senior

Education

BA In Management

Description :

1. Supervised and mentored regulatory team to ensure compliance with state and federal regulatory and statutory requirements including county and municipal agencies.
2. Oversaw company's DOT random drug and alcohol program.
3. Managed field and pipeline inspections in adherence to BSEE, BOEM, DOT, EPA, GLO, PHMSA and USCG compliance.
4. Prepared and submitted emissions calculations for onshore and offshore facility air permits.
5. Reviewed and revised SPCC, OSRP, DPRP & TOM plans.
6. Communicated regulatory information to multiple departments to ensure that information was interpreted correctly.
7. Organized and maintained reporting tools to keep management regulatory apprised of trending compliance tasks and potential challenges.

Experience

2-5 Years

Level

Executive

Education

GED

Description :

1. Wrote notifications in accordance with FDA CFSAN and Health Canada requirements for regulatory submissions.
2. Collaborated with key stakeholders, collecting and compiling needed components and scientific content for initial regulatory submissions, and responding to and addressing FDA and Health Canada follow up questions.
3. Composed FDA and Health Canada notifications and compiled proper attachments in accordance with requirements that facilitated clearance for 15 infant formulas.
4. Maintained Regulatory Filing System for all regulatory submissions and associated communication.
5. Oversaw Serious Adverse Event management and submission to FDA.
6. Compiled and reviewed all information.
7. Obtained needed information by communicating with call center personnel.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Monitored government regulations affecting the business and the legislative process.
2. Researched and interpreted federal and state regulations.
3. Developed and implemented regulatory requirements, policies, and any supporting position paper and rationale documentation as needed by client groups.
4. Assisted in development, implementation and evaluation of process and procedures to ensure compliance with regulations.
5. Provided regulatory support to functional areas.
6. Participated in process improvement working groups.
7. Represented External Affairs Regulatory team in work groups and projects, as assigned.

Experience

2-5 Years

Level

Executive

Education

BA In Broadcast Journalism

Description :

1. Ensured compliance with all federal, state and local regulations pertaining to human subject research, including the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver, and other pertinent regulatory agencies.
2. Provided comprehensive regulatory management for more than 90 clinical trials for the GI/Hepatology Department, including investigator-initiated and industry-sponsored studies.
3. Served as regulatory contact person for ongoing clinical research studies and meet with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
4. Relay timely information regarding protocols to all appropriate clinical staff to ensure compliance with the protocol and all applicable internal and external regulations.
5. Maintained continuous communication with regulatory committees and sponsors prior to and during the protocol development and approval process, and ensure proper communication and follow up.
6. Prepared, submitted, and maintained all Colorado Multiple Institutional Review Board (COMIRB) and Western Institutional Review Board (WIRB) submissions for full board, expedited and exempt trials, including initial applications, amendments, continuing reviews, and trial closures.
7. Developed and negotiated clear and accurated informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations.

Experience

2-5 Years

Level

Executive

Education

Master Of Science In Public Health

Description :

1. Responsible for regulatory reporting to the Texas Railroad Commission with management and compliance.
2. Worked on a daily basis with the Texas Railroad Commission on obtaining the required necessary permitting.
3. Responsible for obtaining licenses and permits as well as keeping complaint on current publications and press Releases.
4. Permitted wells with the Railroad Commission of Texas, R.W.
5. Byram and Company and the Texas Commission on Environmental Quality.
6. Coordinated with city officials, engineers and surveyors to execute deadlines on inside of the city limit permitting.
7. Wrote review summaries.

Experience

10+ Years

Level

Senior

Education

Business Management Technologies

Description :

1. Regulatory Manager Involved in preparing the initial documentation to IRB and follow-up regulatory documentation for over 50 clinical trials.
2. Assisted and communicated with other senior staff to ensure appropriate coordination of clinical trials.
3. Maintained charts.
4. Oversaw the preparation of all closed study files for archiving in storage.
5. Formed and maintained strong working relationships with staff and external customers (i.e., Physicians, IRB, etc.).
6. Performed other duties as needed to support the company.
7. Prepared and collated materials stored in the regulatory binder including all pertinent regulatory documents, correspondence and approved documents.

Experience

10+ Years

Level

Senior

Education

BS In General Studies

Description :

1. Maintained and performed internal quality assurance of regulatory binders.
2. Provided leadership in areas of federal and state student aid regulation.
3. Developed and maintained collaborative working relationships between External Affairs and client group partners/stakeholders.
4. Participated in professional organizations and events to foster relationships.
5. Evaluated in context of FDA reporting requirements, including composing manufacturer's assessment.
6. Wrote cover letter and completed CIOMS / MedWatch forms to FDA and managed all relevant correspondence and document archiving.
7. Responded to notices of potential non-compliance to ensure timely resolution.

Experience

7-10 Years

Level

Management

Education

MS