Medical Research Specialist
3.
3 Full-time 14 hours ago Full Job Description Under the direction of the Drugs and Medical Devices Branch Manager, provides advanced (senior level) medical research and analysis work.
Work involves conducting research and planning, conducting and reporting on medical research projects, assures compliance, planning, design coordinating, and executing of programs and extremely complex scientific projects for the enforcement of the applicable food, drug, cosmetic, and medical device laws and regulations, i.
e.
the Texas Food, Drug and Cosmetic Act, Texas Dangerous Drug Act, Texas Controlled Substances Act, and other specific statues, as well as other cross-over laws.
Provides complex consultative services to the Unit and Section Staff; the Department's staff; state and federal legislators; multiple health care facilities; local, county, state, and federal agencies; city, county, state, and federal law enforcement agencies; multiple and various associations, law firms, consumers; and other international inquiries.
Responsible for annual republishing of controlled substances and rescheduling of controlled substances as required by the Texas controlled substances Act.
Provides technical expertise and oversight in extremely complex scientific projects and the investigations of health fraud and Health and Safety Code violations involving food, dietary supplements, drug products and medical treatments.
Works under very limited supervision with extensive latitude for the use of initiative and independent judgment.
Performs related duties as assigned by the Branch Manager.
Essential Job Functions:
Attends work on a regular and predictable schedule in accordance with agency leave policy and performs other duties as assigned.
Provides extensive, complex, and comprehensive consultative, and scientific services to the Unit and section staff; Department's staff; state and federal legislators; health care facilities; local, county, state, and federal agencies related to drugs, medical devices, cosmetics and dietary supplements.
Reviews Food and Drug Administration newsletters, registers, law blogs and websites in order to interpret and analyze any pertinent legislation or topics relating to drugs and medical devices.
Researches and collaborates with multiple local, state and federal partners to determine multiple courses of actions involving new legislation, new programs and new policies.
(35%) Including but limited to reviewing technical information regarding drug development, scheduling of controlled substances, opioid crisis information, drug shortages, and recalls as it pertains to non-prescription and prescription drugs, medical devices, dietary supplements and cosmetics.
Once research is completed, must convey the technical information to executive management in a clear and concise manner.
Surrounding the information that is gathered, this position must draft new policies and practices concerning drugs, medical devices, dietary supplements and cosmetics.
This position will publish reports to our website, to certain boards, executive management including the commissioner as well as public meetings with stakeholders.
While performing research, may enlist the help of team members and supervise as needed.
(20%) Prepares for publication the schedules of controlled substances annually and reschedules controlled substances as required by the Texas controlled Substances Act.
Develops amendments and annual announcements for controlled substance schedules in accordance with procedures for publication in the Texas Register and for Commissioner approval following publication of any changes in the Federal Register.
(20%) Reviews and processes out-of-state wholesale drug license verification requests to determine compliance with state and federal requirements.
Performs out-of-state license verification request reviews thoroughly, including review of inspectional finds by the U.
S.
Food and Drug Administration, when applicable, and responds within 10 days following receipt of a request.
(10%) Plans and monitors investigations, inspections, and scientific projects for the enforcement of state and federal laws and regulations pertaining to drugs, medical devices, cosmetics, and dietary supplements; including review of labeling, advertising, and websites.
Performs thorough review of inspectional findings, including review of labeling, advertising and websites within legally mandated time frames (e.
g.
Certificate of Free Sale) or in a timely manner as directed.
Synthesizes data and information to ensure that systems, processes, and models developed are internally consistent and achieve the results needed.
(10%) Responds to requests for technical information from customers in a timely manner or as directed and in agreed upon time frames; Performs related work as assigned.
(5%) Knowledge Skills Abilities:
List the knowledge, skills, and abilities critical to performance in this position:
Knowledge of pharmacy compliance and law is preferred.
Knowledge of medical research design, methods, principles, and techniques.
Ability to work with abstract data, concepts, and requests; to prepare clear and concise reports; to communicate effectively Registration or Licensure Requirements:
Initial Selection Criteria:
Graduation from an accredited four-year college in science or related field.
Must have experience in scheduling controlled substances and license verifications.
Masters degree in science or a related field is generally preferred.
Additional Information:
This position will be a combination of office and homebased position.
Applicants will have their driving records checked through the Department of Public Safety and applicants must have a valid Class C Texas driver's license or equivalent license from another state.
Employees/applicants are responsible for providing a copy of their driver's license and college transcript prior to beginning employment.
Those selected for an interview must complete an in basket exercise.
Only applicants who are interviewed will receive written notification of selection results.
Note:
Military occupation(s) that relate to the initial selection criteria and registration or licensure requirements for this position may include:
68S, HM, 870, 4E0X1.
For more information, see the Texas State Auditor's Military Crosswalk at http:
//www.
hr.
sao.
state.
tx.
us/Compensation/JobDescriptions.
aspx HHS agencies use E-Verify.
You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability.
If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747.
If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
HHS agencies use E-Verify.
You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability.
If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747.
If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
PLEASE NOTE:
The posted salary range is the full range for this position.
Agency salary policy, budget and candidate's qualifications will dictate final.
salary offer.
Typically, salary offers are at or near the midpoint of the range, depending on qualifications or other factors.
MOS Code:
67C, HM, 8056, 4E0X1 Top 10 Tips for Success when Applying to Jobs at HHSC and DSHS HHS agencies use E-Verify.
You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability.
If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747.
If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
3 Full-time 14 hours ago Full Job Description Under the direction of the Drugs and Medical Devices Branch Manager, provides advanced (senior level) medical research and analysis work.
Work involves conducting research and planning, conducting and reporting on medical research projects, assures compliance, planning, design coordinating, and executing of programs and extremely complex scientific projects for the enforcement of the applicable food, drug, cosmetic, and medical device laws and regulations, i.
e.
the Texas Food, Drug and Cosmetic Act, Texas Dangerous Drug Act, Texas Controlled Substances Act, and other specific statues, as well as other cross-over laws.
Provides complex consultative services to the Unit and Section Staff; the Department's staff; state and federal legislators; multiple health care facilities; local, county, state, and federal agencies; city, county, state, and federal law enforcement agencies; multiple and various associations, law firms, consumers; and other international inquiries.
Responsible for annual republishing of controlled substances and rescheduling of controlled substances as required by the Texas controlled substances Act.
Provides technical expertise and oversight in extremely complex scientific projects and the investigations of health fraud and Health and Safety Code violations involving food, dietary supplements, drug products and medical treatments.
Works under very limited supervision with extensive latitude for the use of initiative and independent judgment.
Performs related duties as assigned by the Branch Manager.
Essential Job Functions:
Attends work on a regular and predictable schedule in accordance with agency leave policy and performs other duties as assigned.
Provides extensive, complex, and comprehensive consultative, and scientific services to the Unit and section staff; Department's staff; state and federal legislators; health care facilities; local, county, state, and federal agencies related to drugs, medical devices, cosmetics and dietary supplements.
Reviews Food and Drug Administration newsletters, registers, law blogs and websites in order to interpret and analyze any pertinent legislation or topics relating to drugs and medical devices.
Researches and collaborates with multiple local, state and federal partners to determine multiple courses of actions involving new legislation, new programs and new policies.
(35%) Including but limited to reviewing technical information regarding drug development, scheduling of controlled substances, opioid crisis information, drug shortages, and recalls as it pertains to non-prescription and prescription drugs, medical devices, dietary supplements and cosmetics.
Once research is completed, must convey the technical information to executive management in a clear and concise manner.
Surrounding the information that is gathered, this position must draft new policies and practices concerning drugs, medical devices, dietary supplements and cosmetics.
This position will publish reports to our website, to certain boards, executive management including the commissioner as well as public meetings with stakeholders.
While performing research, may enlist the help of team members and supervise as needed.
(20%) Prepares for publication the schedules of controlled substances annually and reschedules controlled substances as required by the Texas controlled Substances Act.
Develops amendments and annual announcements for controlled substance schedules in accordance with procedures for publication in the Texas Register and for Commissioner approval following publication of any changes in the Federal Register.
(20%) Reviews and processes out-of-state wholesale drug license verification requests to determine compliance with state and federal requirements.
Performs out-of-state license verification request reviews thoroughly, including review of inspectional finds by the U.
S.
Food and Drug Administration, when applicable, and responds within 10 days following receipt of a request.
(10%) Plans and monitors investigations, inspections, and scientific projects for the enforcement of state and federal laws and regulations pertaining to drugs, medical devices, cosmetics, and dietary supplements; including review of labeling, advertising, and websites.
Performs thorough review of inspectional findings, including review of labeling, advertising and websites within legally mandated time frames (e.
g.
Certificate of Free Sale) or in a timely manner as directed.
Synthesizes data and information to ensure that systems, processes, and models developed are internally consistent and achieve the results needed.
(10%) Responds to requests for technical information from customers in a timely manner or as directed and in agreed upon time frames; Performs related work as assigned.
(5%) Knowledge Skills Abilities:
List the knowledge, skills, and abilities critical to performance in this position:
Knowledge of pharmacy compliance and law is preferred.
Knowledge of medical research design, methods, principles, and techniques.
Ability to work with abstract data, concepts, and requests; to prepare clear and concise reports; to communicate effectively Registration or Licensure Requirements:
Initial Selection Criteria:
Graduation from an accredited four-year college in science or related field.
Must have experience in scheduling controlled substances and license verifications.
Masters degree in science or a related field is generally preferred.
Additional Information:
This position will be a combination of office and homebased position.
Applicants will have their driving records checked through the Department of Public Safety and applicants must have a valid Class C Texas driver's license or equivalent license from another state.
Employees/applicants are responsible for providing a copy of their driver's license and college transcript prior to beginning employment.
Those selected for an interview must complete an in basket exercise.
Only applicants who are interviewed will receive written notification of selection results.
Note:
Military occupation(s) that relate to the initial selection criteria and registration or licensure requirements for this position may include:
68S, HM, 870, 4E0X1.
For more information, see the Texas State Auditor's Military Crosswalk at http:
//www.
hr.
sao.
state.
tx.
us/Compensation/JobDescriptions.
aspx HHS agencies use E-Verify.
You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability.
If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747.
If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
HHS agencies use E-Verify.
You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability.
If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747.
If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
PLEASE NOTE:
The posted salary range is the full range for this position.
Agency salary policy, budget and candidate's qualifications will dictate final.
salary offer.
Typically, salary offers are at or near the midpoint of the range, depending on qualifications or other factors.
MOS Code:
67C, HM, 8056, 4E0X1 Top 10 Tips for Success when Applying to Jobs at HHSC and DSHS HHS agencies use E-Verify.
You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability.
If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747.
If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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