Project Manager Management

Divya Jaiswal

*****, **** ***** **** ***,

Alpharetta, GA 30004

USA

Mobile- 678-***-****

E-mail: ab1en1@r.postjobfree.com

Objective: To obtain a challenging position that will utilize and further

develop my acquired skills and experience and lead to a

fulfilling career with the right organization.

Experience: 8 years of rich experience in project management, people

management, medical writing, Systematic reviews, Clinical

research, Pharma Regulatory submissions for formulations and APIs

for various regulatory authorities (FDA, EMEA, EDQM, TPD, TGA, MHRA)

& regulatory compliance.

Area of Interest: Operations, Project management, Team management, Client

management.

Domain experience: Drug Regulatory Affairs,CMC, Intellectual Property

Rights,, Evidence based medicine, Systematic review, Medical writing,

Clinical Research, Life Sciences Consultancy

Current Role : Worked as Project manager in HERON Health Private Limited

from Jan 2010 to Sept 2011.

Job Profile

. Managed team of analysts (15) engaged in the medical statistics and

meta-analytical techniques to analyze and interpret data

. Created and executed the project work plans and revised as appropriate

to meet changing needs and requirements.

. Identified resources needed and assign individual responsibilities.

Involved in end to end recruitment.

. Supervised and guided a team of analysts engaged in these projects;

ensure that quality, timelines and budgets of all programs are adhered

. Technically evaluated deliverables prepared by team before passing to

client. Act as a continuous technical support to guide the team across

projects in different therapeutic areas

. Effectively applied methodology and enforced project standards.

. Set up standards for quality control; measure and report performance

against those standards.

. Minimized the exposure and risk on project.

. Suggested and improved overall work processes and training programs

. Scheduled and planned resources .

. Take on people mentoring responsibilities by assuming ownership of a

defined set of individuals and setting their goals; delivering

feedback; planning careers and coordinating appraisals

. Directly engaged with internal and external stakeholders, interpret

their requirements, staff projects and manage the communication flow

throughout

Previous Experience: Worked as Research Associate-II, Regulatory Affairs

(API) in Ind-swift Labs Ltd. Mohali from May 2007 to Jan

2010

Job Profile

. Acted as CMC regulatory project lead to assigned projects by coordinating

regulatory work flow, providing regulatory support to the team, and

tracking timelines and budgets for assigned projects.

. Maintained a working knowledge of, and ensured compliance with,

applicable ICH Guidelines, Regulatory Agency requirements and internal

SOPs aiming to ensure completeness, scientific accuracy, regulatory

compliance, consistency with other key documents and ease of review.

. Review, writing and Submission of DMFs in international markets like US,

Europe and Canada as well as submission of applications to drug

Authority (DCG (I)) in India.

. Review, Compilation and Submission of CEPs to EDQM.

. Responding to the technical queries from Regulatory authorities and

customers to facilitate the in time registrations.

. Filing of Amendments, Annual updates in the respective regions.

. Participate in meetings, and training initiatives, project team meetings,

and maintain relationships with other departments, clients, and

regulatory agencies as necessary.

. Coach, mentor, motivate and supervise project team members and

influence them to take positive action and accountability for their

assigned work.

Previous Experience: Worked as Research Scientist, International Drug

Regulatory Affairs (Formulations) in Dabur Research Foundation Ghaziabad

from Apr. 2006 to May 2007.

Job Profile

. Compilation, Review and Submission of ANDAs, MAAs, ANDSs in regulated

markets like US, Europe, Canada and Australia.

. Handling registration related queries or deficiencies from the respective

regulatory agencies.

. Filing of Amendments, Supplements and Variations in the respective

regions.

. Participation in the regulatory compliance audits at various sites.

Previous Experience: Worked as Executive Drug Regulatory affairs in

Synmedic Laboratories

New Delhi from Sep-2005 to Apr-2006.

Job Profile

. Compilation & Review of Registration Dossiers for Non Regulated Countries

(Vietnam, Combodia, Philippines)

. Preparation of Various regulatory Documents (Free sale certificate,

Certificate of pharmaceutical product)

Previous Experience: Worked as Apprentice (Documentation) in Ranbaxy

Laboratories Ltd., Dewas (M. P.) from Aug-2002 to Aug-2003.

Job Profile

Review of Batch Production Records

. Writing & review of Standard Operating Procedures (SOPs)

Academic Credentials

Particulars Institute/ Year Class/Grade

University

M.Pharm S.G.S. I. T. S, 2006 First (73.54%)

(Medicinal & Indore/

Pharmaceutical R.G.P.V, Bhopal

Chemistry)

PGDBA (Operations S. C. D. L. Pune / 2005 First (66.18%

Management) Symbiosis Deemed /A)

University, Pune

B. Pharm S.G.S. I. T. S, 2002 First (69.73%)

Indore/

R.G.P.V, Bhopal

Higher Secondary V.G.H.S.S/ 1997 First (86%)

M.P.Board

High School V.G.H.S.S/ 1995 First (84.66%)

M.P.Board

Certifications

. Clinical Research training course from National Institutes of Health

(NIH), a part of the U.S. Department of Health and Human Services.

. General course on Intellectual Property Rights from World Intellectual

Property Organization, Geneva (89%)

. Certification in Clinical Research (CCCR) from S. C. H. C. Pune /

Symbiosis International University, Pune.

Research Papers Published in International Journals

. D. Jaiswal, C. Karthikeyan, and P. Trivedi; Rationalization of

Physicochemical Properties of AlkanoicAcid Derivatives towards Histone

Deacetylase Inhibition, Internet Electronic Journal of Molecular

Design 2006, 5, 13-26.

. D. Jaiswal, C. Karthikeyan, S. K. Shrivastava, and P. Trivedi ;QSAR

Modeling of Sulfonamide Inhibitors of Histone Deacetylase, Internet

Electronic Journal of Molecular Design 2006, 5, 345-354.

Trainings/Workshop

. 35 hours of Project management training to acquire 35 PDU fron

Astrowix PMP fast trac.

. Cochrane workshop on Protocol development, systematic review and Meta

analysis at CMC Vellore.

Computer Skills

. Operating Systems: Windows 98/2000, Windows XP.

. Programs Known: C, Fortran, SAP entry

. Modeling Softwares: CS Chem Office (Chem draw), Moe.

. Statistical Softwares: SYSTAT & Valstat, Epi-info

. Basic Internet Skills & Literature searching

. Excellent presentation/ communication skills written and verbal comfort

presenting at senior levels implicit capabilities in MS Word & PowerPoint

Achievements

. National Scholarship holder in 10th and 12th.

. Junior Research Fellowship from Dept. of Pharmacy, S.G.S.I.T.S.,

(A.I.C.T.E.) Indore. (Sep-

2003 to July-2005).

. GATE-02 with 87.63 percentile.

Declaration

I hereby declare that all the statements are true and correct to the best

of my knowledge and belief.

Date:

Place: Alpharetta

Divya Jaiswal

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