SHARI R. BODNOFF, PhD

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862-***-****

January 2021

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Professional

Highlights

Over 27 years in Pharmaceutical and CRO medical writing and operational management, ICF template management, and eConsent.

Work

Experience

12/08 to present, Novartis Pharmaceuticals Corporation, East Hanover, NJ Director Center of Excellence for ICFs (8/18 to presentt)

Responsible for overseeing the updates of ICF templates and creation of new ICFs to ensure consistency.

Work with SME in multiple line function to prepare, review, and finalize content of all ICF templates.

Ensure all ICF templates are health literate (easy-to-understand). Have taken multiple health-literacy trainings

Co-led the ICF end-to-end process to identify gaps and propose solutions

Work with training groups to roll out training for new templates

Work collaboratively with Protocol development leadership to ensure consistency of ICF templates with the protocol template

In 2021, began leading the eConsent. Initiative, working with vendors and end users to pilot the use of remote consent.

Global Head of Operations, Regulatory Writing & Submissions (5/17-4/18); Head, Document Excellence (4/11 to 4/17, Medical & Scientific Writing for Neuroscience and Ophthalmics franchise

(1/10 to 3/11); Group Head, Medical & Scientific Communications & Documentation (12/08 to 12/09):

Fully support and report directly to the VP, Global Head, Document Excellence.

Develop and maintain resource-tracking tools for all documents produced by the medical writing group worldwide (US, EU, IN, CN, and JP). Responsible for integrating other Development Units (Oncology, NIBR, Sandoz, Alcon) into current tracking tools.

Track and report metrics for Global Development Leadership.

Participate in management initiatives related to process, budget/resource tracking, and metrics.

Lead process of identification, assessment, selection, and subsequent oversight/management of all outsourcing within DE (both preferred providers and niche vendors).

Lead preparation for MW audits (both internal and Health Authorities); lead responses to CAPA findings (across GenMeds, Oncology, and NIBR).

Develop and deliver trainings related to outsourcing of patient narratives and CSR QC globally.

Recruited talent; managed performance (set objectives, reviewed performance, and planned compensation) for direct reports located internationally; and developed associates (development/training plans, Organizational Talent Review, coaching or mentoring, as appropriate).

Responsible for direct reports located in India, Switzerland, and the US.

Managed global resourcing, budgets, and metrics.

Oversaw all RMW outsourcing to global vendors (CSRs, submission documents, patient narratives, and CSR QC).

Managed global Neuroscience regulatory and publications writing team (>15 SHARI R. BODNOFF, PhD

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January 2021

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direct reports) in US, EU, and IN.

Subject matter expert on CSR process and QC.

Participated in multiple global, cross-functional initiatives related to outsourcing, metrics, and the end-to-end process.

Lead author of clinical study reports (>20 Phase 3) and clinical submissions (6) in neuroscience, cardiovascular, immunology, and respiratory; reviewed >100 CSRs and submission documents, particularly within Neuroscience. 12/05 to 11/08, Takeda Global Research & Development Center, Inc., Deerfield, IL Manager, Medical Writing

Guided medical writing activities (including document preparation and review) within the Diabetes franchise.

Formulated writing strategy for key response documents and regulatory submissions, including organization, content, timelines, and resource requirements.

Coordinated the activities of Takeda and contract employees (on-site or external) and provided review and substantive editing of contributions.

Created and rolled out new document-review process.

Represented Medical Writing on cross-functional teams and task forces

(related to projects, process, and standards).

11/03 to 10/05, Guilford Pharmaceuticals Inc., Baltimore, MD Associate Director, Medical Writing

Reviewed CSRs and submission documents written by vendors; assisted in preparation of protocols, informed consent forms, and Investigator Brochures.

Prepared time and cost estimates for proposed Medical Writing projects; tracked and managed project-specific timelines and budgets. 11/99 to 10/03, PharmaNet, Cary, NC

Associate Director, Medical Writing (11/02 to 10/03); Manager, Medical Writing (11/99 to 10/02)

Managed medical writing department (~10 writers) in 2 locations; reported directly to Sr. VP of Regulatory Affairs.

Represented Medical Writing during Business Development meetings; prepared time and cost estimates for proposed Medical Writing projects; tracked and managed project-specific timelines and budgets.

Provided oversight for medical writing projects according to SOPs and client standards and developed strategies for organizing and preparing regulatory documents.

Reviewed CSRs, protocols, abstracts, summary documents, and other regulatory documents.

11/98 to 10/99, IBAH Inc., Durham, NC

Manager, Medical Writing

Reviewed regulatory documents; supervised, mentored and trained junior-level writers.

Wrote and edited regulatory documents for US submissions, including CSRs, ISS, ISE, 120-day Safety Updates, and journal manuscripts. SHARI R. BODNOFF, PhD

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January 2021

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Evaluated needs and directed resources for completion of CSRs and regulatory submissions; created project estimates, assessed project status, and managed project timelines.

4/95 to 10/98, Pharmaceutical Research Associates, Charlottesville, VA Proposal Writer (9/97 to 9/98)

Coordinated the in-house proposal process to ensure timely completion of proposals; provided supervisorial, scientific, and editorial support to proposal writing group.

Supported marketing group for new business development presentations.

Medical Writer (4/95 to 8/97)

Sole writer for the clinical portion (6 CSRs, 2 ISSs, and 2 ISEs) of 2 NDAs in a single year (epilepsy and autoimmunity).

Wrote and edited regulatory submissions including CSRs; clinical protocols; ISS and ISE; 120-day Safety Updates; Phase 4, Label- Comprehension Study.

4/94 to 3/95, CatoPharma Canada, Montreal, Canada

Clinical Research Fellow

Wrote and edited regulatory submissions for both US and Canada. Education

McMaster University, Hamilton, CA: Post-doctoral Fellow

(Neuroimmunology: 1993-94).

Concordia University, Montreal, CA: PhD (Neuroscience:1987-93)

Concordia University, Montreal, CA: MA (Behavioral Pharmacology; 1984-87)

Queens University, Kingston, CA: BA (Psychology; 1980-84) First-Author

Publications

S.R. Bodnoff, A. Humphreys, J. Lehman, D. Diamond, G.M. Rose, and M.J. Meaney. “The effects of corticosterone treatment in Long-Evans rats on spatial learning, synaptic plasticity and hippocampal neuropathology.” Journal of Neuroscience 15 1995: 61-69.

S.R. Bodnoff, B.E. Suranyi-Cadotte, R.M. Quirion, and M.J. Meaney.

“The role of the central benzodiazepine receptor in habituation to novelty.” Behavioral Neuroscience 103 1989: 209-212.

S.R. Bodnoff, B.E. Suranyi-Cadotte, R.M. Quirion, and M.J. Meaney. “A comparison of the effects of diazepam versus several typical and novel anti-depressants in an animal model of anxiety.” Psychopharmacology, 97 1989: 277-280.

S.R. Bodnoff, B.E. Suranyi-Cadotte, R.M. Quirion, D.H. Aitken, and M.J. Meaney. The effect of chronic anti-depressant treatment in an animal model of anxiety. Psychopharmacology, 95 1988: 298-301.

S.R. Bodnoff, D.H. Aitken, V. Viau, C.H. vanBerkel, R.M. Sapolsky, and M.J. Meaney. “Individual differences in the adrenocortical stress response and aging.” Journal of Cellular Biochemistry, Suppl 12D 1988: 318.

S.R. Bodnoff, B.E. Suranyi-Cadotte, R.M. Quirion, M.J. Meaney. “Post- natal handling reduces novelty-induced fear and increases

[3H]flunitrazepam binding in rat brain.” European Journal of Pharmacology 144 1987: 105-108.

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