Adair Turner, RAC

3927 W. Aster Dr. * Phoenix, AZ 85029 * 602-448-0270 *

SUMMARY
Results oriented Project Management and Regulatory Affairs professional with ove
r 7 years of Oncology drug development experience.
Key accomplishments:
* Led the planning, review, and delivery of multiple, high-quality global regul
atory submission dossiers in support of the development and registration of anti
-cancer compounds.
* Created, maintained, and optimized integrated project plans and effectively c
ommunicated and gained consensus with multi-disciplinary project teams on tasks,
responsibilities, and timelines.
* Developed standardized processes and provided training and expertise in the r
equirements of dossier preparation, format, and publishing.
* Defined, assessed, and improved tracking, quality control, Health Authority c
ommunication, information request, document review, archiving, technology, and p
ublishing processes to greatly increase productivity.
* Prepared and demonstrated planned electronic submission with Director of Elec
tronic Submissions for CBER at FDA.
Oncology projects:
* REVLIMID(r) (lenalidomide) label update in Multiple Myeloma and Del 5q Myelod
ysplastic Syndromes with new starting dose guidelines for patients with renal im
pairment
* ERBITUX(r) (cetuximab) expanded labeling (SCCHN; CRC; KRAS Voluntary Genomics
Data)
* IMC-A12 (cixutumumab), IMC-1121B (ramucirumab), and IMC-11F8 (necitumumab) in
itial IND applications
* IMC-A12 (cixutumumab), IMC-1121B (ramucirumab), and IMC-11F8 (necitumumab) Ph
. II & III global CTAs and clinical trial management in more than 10 countries
* New, multi-suite biologics manufacturing facility
* 11F8 (necitumumab) Ph. II CTA in Spain and Belgium
* ERBITUX(r) (cetuximab) BLA for CRC (electronic publisher)
EDUCATION
Arizona State University, Phoenix, AZ
M.S. in Clinical Research Management, December 2010
* Designed a clinical research study and wrote a protocol, project management p
lan, data management plan, budget, and contract.
* Capstone Project: Performed a Cost Effectiveness Analysis of a regulatory reg
istration tracking, document management, and eCTD submission technology implemen
tation at Ventana (Roche) Medical Systems to determine ROI.
Rutgers University, New Brunswick, NJ
B.A. in Communications and English, December 2002
EXPERIENCE
Arizona State University, Phoenix, AZ
Graduate Clinical Research Associate (CRA), August 2009 - Present
* Duties include recruitment and enrollment of human subjects, preparation of s
ubject instrument packets, protection of subjects and subjects' rights through I
RB relations, obtaining informed consent and HIPAA waiver, data collection, moni
toring, creation of clinical study tracking database, clinical information data
entry and verification, and subject follow up.
 * Develop and maintain collaborative working relationships with clinical invest
igative sites and ensure site understands protocol requirements, study conduct,
and adherence to regulatory requirements.
Celgene Corporation, Summit, NJ
Manager, Regulatory Affairs, September 2008 - June 2009
* US regulatory strategy leader for REVLIMID(r) (lenalidomide).
* Planned, implemented, and managed identified projects (annual reports, FDA pr
e-meeting materials, etc.).
* Researched and reported Regulatory intelligence, strategy, assessment, and co
mpetitive analysis.
ImClone Systems Incorporated, Branchburg, NJ
Manager, Regulatory Operations, August 2006 - September 2008
* Led Regulatory sub-team that included Regulatory and Clinical CRO, Clinical A
ffairs, Clinical Operations, Pharmacology, and CMC functions.
* Interpreted ethics committee and competent authority regulations/country spec
ific requirements and provided logistical/documentation tracking support for mor
e than 20 new clinical trials for three development compounds (A12, 1121B, 11F8)
globally.
* Assessed budget needs and managed the Finance and Legal processes for procure
ment and contracts.
* Authored and reviewed work instructions and standard operating procedures.
* Responsible for oversight of temporary employees. Led and developed staff vi
a training plans, coaching and mentorship.
Regulatory Affairs Associate/Publisher, January 2003 - August 2005
* Published and submitted an electronic Biologics License Application (eBLA) fo
r Erbitux(r) (cetuximab) in CTD format as well as subsequent amendments, supplem
ents, post approval commitments, and inspection responses.
* Planned, reviewed and submitted post-marketing materials to DDMAC for review
and approval.
* Member of the cross-functional team responsible for Document Management Syste
m implementation.
* Created electronic and paper filing system and was accountable for organizati
on, maintenance, archival and reporting of all global health authority communica
tions in accordance with regulatory and legal requirements.
* Member of Regulatory FDA Inspection Team.
* Led company transition from paper submissions to eCTD.
SKILLS
* Advanced Project Management, decision making, highly developed problem solvin
g, reporting, and research.
* Budget and contract development and administration.
* Experience with process improvement, clinical research study design and proto
col development, cost effectiveness analysis, data management and analysis.
* Demonstrated knowledge of the drug development process, Health Authority regu
lations, guidance documents (US, EU, CAN), and ICH technical aspects of product
registration.
* Attention to detail and accuracy.
* Understanding of CTD/eCTD.
* Communicates, coordinates and interacts with all levels of management and oth
er departments effectively.
* Proficient in Microsoft Office, clinical trial and electronic submissions sof
tware, and tracking databases.