LISI WANG

(US permanent resident)

State College, PA 16801
E-mail: <lisiwang@yahoo.com>
Phone : 1-416-877-0058

OBJECTIVE: To seek a growth opportunity in US pharmaceutical industry, a role in the

clinical research area of Medical Writing.

SUMMARY OF QUALIFICATION
 Over 9 years of practical experience with global pharmaceutical companies, esp. clinical
trial-related Medical Writing (over 2.5 years) for regulatory purpose and
Pharmacovigilance/Drug Safety (over 4 years).

 Ability to set up and manage high quality systems, from pharmacovigilance to clinical
trial-related medical writing.

 Demonstrated comprehensive knowledge in regulatory compliance,

pharmacovigilance & clinical trial process and strategic application of FDA
regulations, ICH, GCP; proven working knowledge of scientific principles and all phases
of clinical research; ability to summarize complex data and identify relationships.

 Master degree from pharmacology and M.D. degree.

 Demonstrated good record of effective team/interpersonal skills; ability to manage multiple tasks;
and provide creative and practical solutions.

SUMMARY OF SKILLS
 Technical Well developed in writing US regulatory submission-ready reports (drug
writing: safety and clinical trial reports), SOPs, working practice documents,
protocols, essay & grant proposals, research papers, posters, newsletters.

 Computer: Proficiency with Microsoft Office (Word, Powerpoint, Excel,

Access), WordPerfect, Lotus, Outlook and Internet for research.

 Languages: Fluent in written and oral English & Mandarin, some knowledge of French

 Science: Good knowledge of scientific methodology & procedures applied in

pharmaceutical industry.

 Interpersonal: Motivated team player and independent worker, with excellent analytical &
communication skills, both verbal and written; capable of managing a group
of personnel toward achieving collective results.

 Personal: Efficient and detail-oriented individual who works well under pressure with
strong organizational and project management skills to produce high quality
work; capable to set up a new system/line of work from scratch; eagerness &
aptitude for learning new tasks quickly.

LiSi Wang, Resume

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EMPLOYMENT EXPERIENCE

Aug. 2007 – Present Supervisor, Medical Writing group, Pfizer Research & Development
Center, China
 Set up and leading the local Medical Writing group to provide input to global regulatory submission
by interpreting clinical trial results with clinicians, biostatisticians, clinical pharmacology specialists and
principle investigators, facilitating key message meeting and results review meeting with clinical study
team members, effectively implementing medical writing process, independently writing, reviewing and
QC FDA/ICH-compliant clinical documents (all English), eg. clinical study reports
(including all efficacy, PK/PD, safety narratives and safety results for full CSR, synopsis CSR, core
CSR), PhRMA Web Synopsis, CTD documents, clinical protocols for various
Pfizer global clinical trials, according to ICH and Pfizer global standards, in various
therapeutical areas (metabolism, inflammation, pain, ophthalmology, cardiovascular, endocrinology,
neurology, allergy, respiratory and oncology).
 Established new-hire training strategy and system; developed project management & quality metrics
tool and system; facilitated external & internal audit and inspection.
 Being a people manager; involved in interviewing, hiring and mentoring new staff.

Feb. 2006 - Jul. Senior Pharmacovigilance Specialist, Baxter

2007 Corporation, Canada
 Established and maintained an efficient pharmacovigilance system by setting up electronic
tracking system, training system; developing SOPs & working practice documents; supporting global
ADR/AE database (AERS); joining in Baxter global medical doctor team to create the convention of
vigilance strategy for global usage; facilitating Canadian inspections and corporate audits; creating
internal departmental website.
 Conducted pharmacovigilance activities: collect, investigate, process, document and report all
applicable local and foreign ADRs from post-marketing & clinical trials in accordance with global
and national regulations and procedures; detect potential safety signals and assess the relevant data to
evaluate benefits and risks of Baxter products.
 Established appropriate contacts with external parties (FDA & Canadian regulatory authority,
health care professionals, distributors) and internal parties (Baxter global pharmacovigilance,
regulatory affairs, quality, sales & marketing); answer safety-related inquiries; provide input to
Regulatory Affairs in product labels/monographs and input to sales & marketing in
contracts/agreements
 Set up and implemented a training program to train customer-facing personnel (e.g. sales rep,
customer service, etc) to enhance the awareness of the importance in monitoring drug safety and the
visibility of pharmacovigilance function within the company.

Dec. 2003 -Feb. 2006 Pharmacovigilance/Medical Information Specialist, Genpharm Inc.

(A Division of Merck KGaA, Germany), Canada
 Conducted pharmacovigilance activities: AE coding (MedDRA); collect, review, and assess all
safety data; write and report individual AE case report (15-day report), PSUR/PADER, special safety
reports, communicate with FDA/TPD for drug safety issues.
 Conducted medical information tasks: provide verbal or written medical or drug-safety
information to consumers, health care professionals and marketing department upon request.
 Established and organized local database to manage and track all drug safety cases and activities;
performed routine case review; supported global pharmacovigilance database (ARISg), actively
involved in the creation and implementation of strategies to improve operations; Initiated SOPs and
change controls.

LiSi Wang, Resume

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Jul. 2001 - Dec. 2003 Senior Analyst, Quality Dept., Genpharm Inc. (A Division of Merck
KGaA, Germany), Canada
 Coordinated the work within the group and liaised with internal and external parties (e.g. suppliers, USP,
BP, EP, etc); performed various analytical tests by applying analytical techniques and instruments such
as chromatography, spectroscopy, wet chemistry, etc.; trained and mentored other analysts.

Sep. 1999 - Jul. Research Assistant, Banting & Best Dept. of Medical
2001 Research, University of Toronto, Canada
 Established & validated luciferase reporter gene system to assess PKC signal transduction pathway.

Sep.1997 - Mar. Research Associate, Institute of Genetic

1999 Engineering, Fudan University, China
 Studied the Retinitis Pigmentosa (RP) by performing molecular genetic methods: PCR, SSCP,
agarose & polyacrylamide gel electrophoresis, DNA sequencing.

ADDITIONAL EXPERIENCE
Mar. 1999 - Mar. 2000 Medical writer (part-time) for clinical trials, Zipharm International Inc, Canada.
Sep. 1999 - Sep. 2000 Teaching Assistant, Dept. of Pharmaceutical Science, University of Toronto,
Canada.
Mar. 1999 - Sep. 1999 Volunteer in Pharmacy Information Center, Toronto General Hospital, Canada.

EDUCATION
Jan. 2003 - Jul. 2007 Pharmaceutical Regulatory Affairs and Quality Operations Post Graduate
Diploma Program (part-time), York University, Canada.

Completed courses: Pharmaceutical Regulatory Affairs; Quality Assurance;

Biotechnology & Biopharmaceutical; Product Formulation & Pharmaceutical
Manufacturing.

Sep. 1999 - Sep. 2001 Master of Science, Dept. of Pharmacology, Faculty of Medicine, University of
Toronto, Canada.

Sep. 1992 - Sep. 1997 M.D, Shanghai Medical University, China (including internship in hospitals).

Academic awards:
1999 - 2001 University of Toronto Fellowship, Canada.
1993 - 1996 Scholarship for Outstanding Personality & Studies, Shanghai Medical University, China

ACTIVITIES
Memberships: DIA (Drug Information Association, US); PSG (Canadian Pharmaceutical Science Group);
CAPRA (Canadian Association of Professional Regulatory Affairs)

Trainings: Pfizer CRA Certification Program; SoCRA (Society of Clinical Research Associates, US);
CanReg (Canada)

Certificates: Pfizer Leadership; Professional Project Management; Clinical Trial Design; First Aid with CPR.

REFERENCES Available Upon Request

LiSi Wang, Resume

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