Jodie L. Stennett

*** ********* *****

Royersford, PA 19468

847-***-****

acgdn6@r.postjobfree.com

HIGHLIGHTED SKILLS: Over 7 Years of Regulatory Submissions Experience

* ***** ********** *******ons 1 eCTD MAA and 2 NeeS Int’l Submissions

Experience 3 eCTD Original IND Submissions

3+ Years Regulatory Affairs Experience

1 eCTD NDA Submission 1 Successful BLA and sBLA Approval

EDUCATION:

• Northern Michigan University, Bachelor of Science Degree in Biochemistry

• Illinois Institute of Technology (Attended 2 Years), Masters of Chemistry Program, GPA 3.55

WORK EXPERIENCE:

Sr. Regulatory Affairs Associate, CSL Behring, King of Prussia, PA, 10/2012-present

• Regulatory Project Lead for 1 project. Prepare all required regulatory documents and provide

strategic advice to cross-functional teams.

• Assisted with the preparation of documents (Responses to FDA’s Request for Information) for the

successful FDA approval of 1 BLA and 1 BLA clinical efficacy supplement.

• Review, prepare and/or compile IND amendments (4 projects), Original BLAs (1 project), BLA

amendments, and BLA efficacy supplements (1 project).

• Write cover letters, forms, meeting requests and orphan drug applications. Assist with the preparation

of meeting background packages.

• Review Protocols, IB’s, Annual Reports, DSURs, and CSRs.

Sr. Regulatory Associate, MedImmune, Gaithersburg, MD, 06/2011-10/2012

• Managed the submission of 1 eCTD original IND within established timelines.

• Responsible for the submission of all IND amendments (3 projects).

• Prepared cover letters and forms. Wrote regulatory strategy documents.

• Led and participated in cross-functional project teams meetings for regulatory strategy of IND and

CTA submissions.

• Reviewed IMPDs/CTAs, DSURs, Protocols, ICFs, and IB’s.

Submissions Manager/Manager, Regulatory Operations, Emergent BioSolutions, Gaithersburg, MD,

01/2009-06/2011

• Planned, managed and executed activities associated with this submission of 2 original eCTD INDs,

1 MAA and 2 NeeS including managing submission timelines and overseeing publication activities.

• Responsible for publishing (paper) and overseeing the publishing (electronic) of all other FDA

submission, including but not limited to, IND amendments, BLA supplements, annual reports, briefing

packages, development plans and promotional material.

• Formatted regulatory documents in accordance with internal style guides and templates (Starting

Point). Advanced MS Word and PDF capabilities and knowledge.

• Wrote departmental/global SOPs, style guides and work procedures.

• Mentored and trained junior staff.

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Submissions Team Leader/Manager, Regulatory Affairs, Advanced Life Sciences, Woodridge, IL,

04/200*-**-****

• Assisted with the successful submission of an eCTD NDA with contribution as the Submission Team

Leader. 285,000 page (550 documents) eCTD NDA submitted within established timelines.

• Responsible for overseeing the electronic publication and review activities (QC of bookmarks and

hyperlinks) for all Module 1 to Module 5 documents in order to make all documents submission-ready.

Responsible for Module 1 to Module 5 document QA, and MedDRA and Con Med coding

•

review (10,000 terms each).

Mentored and trained junior staff.

•

Sr. Regulatory Affairs Associate (2007-2008)

• Daily management of eCTD NDA submission activities in regards to meeting submission and

publishing timelines, overseeing electronic publishing of NDA-related documents, resolving clinical

data and documentation issues, organizing, planning and leading team meetings and oversight of NDA-

related vendors and consultants.

• Assisted in the compilation, submission and maintenance of IND regulatory submissions.

• Wrote departmental SOPs.

Clinical Research Scientist (2006-2007)

• Maintained daily oversight of 2 Global Phase III Clinical Trials (19 countries, 200 sites), including

tracking patient recruitment, resolving site and clinical data issues, budget and contract negotiations,

and identification, selection and management of CRO and vendors.

• Wrote and/or reviewed clinical trial protocols, IB’s, CRFs and ICFs.

Clinical Research Associate, TAP Pharmaceutical Products, Lake Forest, IL, 05/2005-03/2006

• Daily management of site and vendor communication and issue resolution including, but not limited

to enrollment, screening, PDAs/eDiaries, Interactive Voice Response System, lab supplies, EDC, and

site recruitment material.

• Assisted with writing, review and QA of protocols, ICFs and other related clinical study documents.

Sr. Clinical Research Associate, Presutti Laboratories, Rolling Meadows, IL, 04/200*-**-****

• Wrote clinical study protocols, informed consent forms and IB’s. Developed CRFs.

• Initiated and administered site budgets and investigator contracts.

Clinical Data Associate, Fujisawa Healthcare, Deerfield, IL, 10/2000-03/2004

• Managed 20+ clinical studies (paper-based and EDC). Performed all data management related tasks

in order to provide complete, consistent and accurate databases for analysis.

• Validated EDC system for the capture of clinical data. Produced validation documentation including,

but not limited to, validation plans, functional requirements, system specifications, 21 CFR Part 11

compliance assessment, test scripts, and validation reports.

Quality Assurance Document Analyst (2000-2001)

• Performed manual and electronic audit/QA of IND and NDA related documentation, including non-

clinical and clinical study reports, annual reports and protocols.

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