Sr. Medical Writer

EDUCATION

**/**** ****** ** *******, Biomedical Sciences

University of Medicine and Dentistry of New Jersey,

Newark, NJ

**/**** ******** ** *******, Chemistry

University of Southern California, Los Angeles, CA

EXPERIENCE

01/2011 - 01/2013 Sanofi-Aventis Pharmaceuticals, Bridgewater, NJ

Sr. Medical Writer (Consultant)

Responsible for timely writing and editing of phase I to III clinical

study reports (CSRs), ensuring high quality with regard to scientific

content, organization, clarity, accuracy, and adherence to company style

guides and standard operating procedures (SOPs),

Arranges and leads interdisciplinary clinical meetings,

Arranges and leads Ad hoc meetings.

08/2009 - 01/2011 Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Sr. Medical Writer, Clinical Sciences, Medical Writing

(Consultant)

Responsible for the writing of phase I to III CSRs,

clinical study protocols (CSPs), investigator's

brochures (IBs), and Clinical Summaries,

Writes patient and safety narratives,

Tracks writing projects in a therapeutic area,

Ensures adherence to regulatory guidelines, and works

with members of the department to help set department

document standards.

07/2008 - 07/2009 Sanofi-Aventis Pharmaceuticals, Bridgewater, NJ

Sr. Medical Writer (Consultant)

Responsible for timely preparation and editing of phase

I CSRs, ensuring high quality with regard to scientific

content, organization, clarity, accuracy, and adherence

to company style guides and SOPs,

Arranges and leads interdisciplinary clinical meetings,

Arranges and leads Ad hoc meetings,

Responsible for the production of 100 patient

narratives.

05/2007 - 05/2008 Medarex, Bloomsbury, NJ

Sr. Medical Writer (Consultant)

Writes patient and safety narratives for BLA submission,

Provides Clinical Team support,

Responsible for clinical document production and

finalization, including the management of review and

approval process,

Responsible for timely preparation and editing of IBs,

CSPs, CSRs, IND annual reports, integrated summaries,

clinical summaries, informed consent forms, and other

IND / CTA and global regulatory submission documents,

ensuring high quality with regard to scientific content,

organization, clarity, accuracy, format, consistency,

and adherence to regulatory and internal guidelines,

style, and processes.

06/2006 - 05/2007 The Medicines Company, Parsippany, NJ

Sr. Medical Writer (Consultant)

600 plus patient narratives,

Writes and edits CSPs / protocol amendments, IBs, annual

reports, CSRs (all phases), manuscripts, abstracts,

integrated summaries and clinical overviews on deadline,

Works with biostatisticians and programmers to gather

and analyze data for CSRs and investigator's brochure

updates,

Researches scientific documents for source information,

appraises and recommends references that support text

statements,

Creates and maintains clinical document templates in

accordance with pharmaceutical standards and regulatory

guidelines and requirements,

Leads critical review process of clinical and regulatory

documents,

Collaborates with Investigators and publication

committees to develop abstracts, manuscripts and

poster/slide presentations. Manages projects, including

quality control steps, delegates appropriate tasks, and

oversees completion of tasks within established

schedules and timelines.

07/2005 - 06/2006 ImClone Systems, Branchburg, NJ

Sr. Medical Writer (Consultant)

Writes, reviews, and edits, as necessary, CSPs /

amendments, IND annual reports to regulatory

authorities, CSRs, regulatory documents (eg, clinical

sections of an IND, dossiers, or a BLA / NDA), ad hoc

clinical reports, publications, and related documents,

Writes, reviews, and edits, as necessary, presentations,

posters, abstracts, etc containing clinical data,

Writes, reviews, and edits, as necessary, departmental

SOPs,

Assists with the integration of clinical trial

data/information into concise and uniform reports for

journal submission or non-routine submission to

regulatory authorities,

Assists with the circulation of clinical / medical data

/ information via reports to departmental and Company

employees as directed,

Prepares timely summary reports of the status of all

responsible projects,

Assists with the interaction of database management

staff (either in-house or vendor) to provide appropriate

data output for the timely completion of required

responsibilities,

Maintains technical proficiency and professional skills

through literature review and attendance at conferences,

seminars, courses, or clinics.

01/2004 - 01/2005 Sanofi-Aventis Pharmaceuticals, Bridgewater, NJ

Sr. Medical Writer (Consultant)

Manages and executes the review, approval and

publication of over 100 clinical SOPs,

Outsources work to authors in Medical Affairs,

Biostatistics, Global Pharmacovigilance, and Regulatory

Affairs,

Co-ordinates all assigned projects from concept to

publication,

Writes/edits templates for the: IB, CSR, CRF, PSUR,

others,

Facilitates discourse between departments, fact checks

as necessary,

Builds necessary relationships with senior management in

Clinical Research.

07/2002 - 01/2004 Pfizer, Inc., Morris Plains, NJ

Senior Scientific / Medical Writer (Consultant)

Lead writer for Technical Affairs department,

Provides writing support to company personnel in Medical

Affairs and Quality departments,

Updates various study related documents within specific

drug programs,

Writes Protocols, Reports, SOPs, Product Label

information,

Interacts with Global Quality in writing product

reports,

Interacts with senior management, facilitate meetings as

necessary,

Creates, edits and reformats documents according to ICH,

and FDA, requirements.

01/1997 - 12/2001 Qual Quan Research, Inc., East Orange, NJ

Senior Scientific / Medical Writer (Consultant)

Prepares technical documents to support both domestic

and international research projects,

Incorporates raw data: text, graphs, charts, tables and

statistical analyses; proof reads, circulates, edits,

assembles, inspects, and critiques various reports,

Writes medical abstracts. Edits scientific manuscripts,

posters and other material in support of the client's

marketing and sales efforts,

Writes and reviews scientific material, tracking

milestones and delivery dates as well as ensuring the

quality of deliverables. Writes sections of

Investigator's Brochure, study protocols,

Works on Clinical Trial data from: Phases: I through IV.

01/1995 - 01/1997 Gilead Sciences / Nexstar, Inc., San Dimas, CA

Medical Writer (Consultant)

Prepares and organizes regulatory documentation for

submission to government agencies. Helps maintain

regulatory compliance pertaining to conduct of clinical

development activities and regulatory operations,

Medical writing responsibilities: study protocols, etc,

Assembles, prepares for review and submits regulatory

documentation such as INDs, NDAs, Investigator's

Brochure, etc,

Interacts verbally and in written fashion with

regulatory agencies under the general direction of

department director,

Performs quality audits of internal clinical trial

documentation,

Maintain schedule of audits,

Reviews and processes Adverse Event reporting to FDA and

other regulatory agencies,

Ensures regulatory submissions are accurate and

verifiable against source documents (case report forms,

etc.) to confirm compliance and traceability,

Assists in departmental audits of Clinical Operations,

Clinical Research and Quality Assurance,

Reviews and approves investigational labeling for

regulatory compliance,

Reviews and supports implementation of current policies

and practices issued by US and international regulatory

agencies. Maintains ongoing review of regulatory

publications,

Participates in the development, writing and maintenance

of departmental SOPs.

01/1994 - 01/1995 Medtronic Cardiopulmonary, Inc., Anaheim, CA

Technical Writer II / Quality Control Chemist

(Consultant)

Develops and documents systems / production and QA / QC

SOPs,

Generates SOPs for new and existing processes in

accordance with FDA guidelines,

Reviews / edits medical device insert material,

Performs laboratory analyses on various cardiopulmonary

devices.

02/1993 - 01/1994 Pharmavite Corporation, Inc., Glendale, CA

Technical Writer II / Quality Control Chemist

(Consultant)

Laboratory analyses: dissolution testing, LOD, particle

size, stability testing, wet chemistry etc,

Generates new calibration, operational, other SOPs,

Document review,

Revises and manages compliance documents in support of

Production and Quality Control operations. Ensures that

proposed changes are documented, defined and reviewed

for impact on equipment qualification, process

validation and compliance, and oversees draft documents

through the review, approval and distribution process.

03/1990 - 02/1993 Hoffman La Roche, Inc., Nutley, NJ

Assistant Scientist / Technical Writer

Laboratory analyses: HPLC, particle size testing,

particulate matter, dissolution testing, X-ray

diffraction, etc,

Revises analytical methods and SOPs,

Document review,

Audits laboratory notebooks for GLP compliance.

06/1989 - 02/1990 E.V. Roberts & Associates, Inc., Culver City, CA

Chemist / Technical Writer

Develops product manuals, and Technical Data Sheets,

Writes and revises SOPs, Safety Reports,

Quality Control Laboratory Analyses.

TECHNICAL SKILLS

Computer Skills

MS Office Suite (Word, Excel, Power Point, Access, Publisher)

MS Outlook

Adobe Acrobat

Documentum

PDOCS electronic document management system

Quick Study Capture by e-trials

THERAPEUTIC EXPERIENCE

Diabetes

Cardiovascular

coronary heart disease

atherosclerosis

Oncology

solid tumors

tumor metastasis

hematological malignancies

Exploratory / Internal Medicine

respiratory diseases

auto-immune diseases

CNS

neurologic disorders

psychiatric disorders

Immunology

Immunomodulators

Antihistamines

CERTIFICATIONS

Certified Medical Writer, Pharmaceutical Training Institute

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