JAYASHREE MITRA Ph.D.

*** ****** **** *****, ***** Brunswick, NJ 08902

Res: 732-***-****• Cell: 908-***-****

achav3@r.postjobfree.com

Objective: To obtain a medical writing position in the pharmaceutical industry/academia.

Total number of years of pharmaceutical industry experience: 5+

Professional summary:

• Proven track record of clinical writing project management and working in a complex, multinational,

matrix environment and with CRO/vendors

• Strong attention to detail and accuracy of medical writing content

• Ability to manage multiple projects simultaneously to ensure completion within timelines

• Extensive late phase regulatory document writing, publications, data presentation experience

• Solid understanding of ICH/GCP guidelines and other standard regulations

• Self-motivated, values relationship building and teamwork, strong oral and written communicator

• Skilled in AMA Manual of Style and Vancouver Reference Style Guide, clinical trial management system

(Documentum)

• Strong knowledge of diverse therapeutic areas: oncology (colon cancer, breast cancer, lymphoma),

hematology, respiratory and cardiovascular medicine, dermatology, transplantation and immunology

Current Role: Tata Consultancy Services (TCS) Onsite Liaison and Peer reviewer at Novartis

Pharmaceuticals, East Hanover NJ, (reporting to TCS Life Sciences Domain Head)

10/2013-present

Number of years in TCS: 1+

Role Description:

• Acting as the onshore point of contact between TCS and Novartis US, EU Clinical teams, and the

Regulatory Medical Writing team (RMW)

• Contact Novartis clinical teams for new projects and conduct introductory meetings to assess narrative

writing requirements; convey requirements to offshore writing team

• Active participation in project kick off meetings, review narrative templates, data sources and liaise

between medical writers and the clinical teams on issue resolution.

• Review narratives authored by writers to ensure accuracy, adherence to FDA regulations, SLAs and

KPIs

• Author and QC narratives for critical submission projects (if necessary, depending on priority)

• Drive quality improvement initiatives such as process improvements and training of writers

• Actively manage issue escalation (lessons learnt practices with Clinical teams, face to face discussion)

with clinical teams, RMW and writers

Previous Employment Summary:

Medical Writer (reporting to Director, RMW)

Daiichi Sankyo (Clinical Development and Operations), Edison, NJ 11/2011-4/2013

Lead:

• 2 study conduct, governance and quality oversight NDA submission documents for large Phase 3

studies

o Designed template for the documents

o Managed cross-functional teams across US, Europe and India to obtain input/deliverables/ reviews

and revisions within tight timelines

o Steered drafts through multiple review cycles

o Obtained quality assurance and quality control inputs

• Several Phase 2 and 3 clinical protocols

o Obtained and managed input/deliverables across cross-functional teams in Europe, US, KOLs

o Participated in Steering Committees to update study designs and clinical protocols

Page 1

JAYASHREE MITRA Ph.D.

999 Hidden Lake Drive, North Brunswick, NJ 08902

Res: 732-***-****• Cell: 908-***-****

achav3@r.postjobfree.com

o Obtained quality assurance and quality control inputs

o Managed tight timelines successfully

o Steered multiple drafts through review and revision cycles with final sign off in Documentum

Co-lead:

• eCTD 2.7.4 modules, Investigator brochures, CSRs, patient safety narratives

• Performed quality control of the following documents: Protocols; Briefing Book and Appendices; Trigger

Term Document; IB and CSRs

• Designed RMP template

• Updated SOPs

• Safety data review for 2 submission studies

Self Employed (worked part time because of elder care issues), 1/2008-10/2011

Home-based freelance medical writer for NIH, Nature Scitable, Yes Doc. LLC and others

• Federal grant proposals and news contents for NIH

• Scientific manuscripts, journal articles, KSAs and teaching philosophies

Clinical Research Scientist (reporting to Oncology Clinical Program Manager),

Merck & Co. (Clinical Oncology), North Wales, PA 8/2006-04/2007

Lead: Phase 2, 3 and combined Clinical protocols, IBs, Informed consent, CSR, DSMB charters

• Gathered input from local and global teams, external experts and collaborated with team to address and

resolve issues

• Collaborated with monitor, statistician and Merck’s internal upper level management to revise protocol

under tight timelines; participated in team and study meetings to review and resolve issues

• Multitasked to update IB, Risk Language, Informed Consent Forms, DSMB charter

• Made slide presentations for Investigator meetings

• Reviewed set up of IVRS, ancillary supplies, laboratory and study drug supplies, laboratory contracts,

and vendor selection

• Reviewed patient recruitment and retention challenges, site readiness, study close out and CSR

tracking

Research Assistant Professor, (reporting to Chairman, Molecular Biology Department)

Drexel University, Philadelphia, PA 07/2004-05/2006

Lead: Regulation of APC by cell cycle genes

Gene expression variability in breast cancer

• Designed and managed project from inception to completion: reviewed literature to develop outlines and

work plans for the project, designed experiments, directed technicians and students to perform

experiments, discussed results and provided direction to future line of work

• Published research results in a peer-reviewed biomedical journal: wrote manuscript, addressed

comments from reviewers and journal editor to incorporate changes

• Interacted with a senior member to strategize research plans, laboratory and project management,

interviewed prospective candidates for the department

• Presented research In-House and at National Conferences

Page 2

JAYASHREE MITRA Ph.D.

999 Hidden Lake Drive, North Brunswick, NJ 08902

Res: 732-***-****• Cell: 908-***-****

achav3@r.postjobfree.com

Research Associate and Assistant Professor (reporting to Associate Professor, GI Division)

University of Pennsylvania Health System, Philadelphia, PA 6/1999-6/2004

Lead: Cell cycle Regulation in Cancer; Use of RNAi to suppress cell cycle protein expression

Supportive: Drug-induced regulation of gene expression and cell growth in vivo

• Worked as a mentored-scientist and wrote a successfully-funded NIDDK-K01 grant

• Developed several cell-based, biochemical assays and RNAi techniques

• Published several scientific manuscripts, abstracts and reports in peer-reviewed biomedical journals;

communicated with editors to resubmit manuscripts within tight timelines

• Presented within the department and in National Conferences

• Worked as the laboratory safety officer and served as ‘point of contact’ for department members on cell

cycle research issues

Education and Training

Doctorate in Science (Endocrinology and Biochemistry), 1991

University of Jadavpur, Calcutta, India

Post-Doctoral Training, 1994-1998

Departments of Biology and Medicine

University of Pennsylvania, PA

Awards

Indian National Scholarship for Graduate Studies

University of Calcutta Gold Medal in M.Sc.

Rockefeller Foundation Postdoctoral Career Award

NIH Research Career Award

Professional Memberships:

AMWA

NJAPM alternative dispute resolution and civil mediation

Personal:

Nationality: USA; Indian Overseas Citizenship

Last 4 digits of SSN: 48029

Publications (the list below only includes papers authored and does not include manuscripts/publications

arising out of freelance work)

*Corresponding author

Mitra J*, Enders GH, Azizkhan-Clifford J and Lengel KL. Dual regulation of the anaphase promoting

complex in human cells by cyclin A-Cdk2 and cyclin A-Cdk1 complexes. Cell Cycle 5(6): 661-6. 2006.

Mitra J*, Enders GH*. Activation of Cdk1 and Cdc25 phosphatases is regulated by Cdk2-cyclin A

complexes in human cells. Oncogene: 23(19): 3361-3367, 2004.

Hu B, Mitra J, van den Heuvel S and Enders GH*. S and G2 phase roles revealed by inducible

expression of a dominant negative mutant in human cells. Molecular and Cellular Biology 21(8): 2755-

66, 2001.

Page 3

JAYASHREE MITRA Ph.D.

999 Hidden Lake Drive, North Brunswick, NJ 08902

Res: 732-***-****• Cell: 908-***-****

achav3@r.postjobfree.com

Krauthauser CM, Hall LA, Wexler RS, Slee AM, Mitra J, Enders GH and Kerr JS*. Regulation of gene

expression and cell growth in vivo by tetracycline in the hollow fiber Assay. Journal of Anti -Cancer

Research 21(2A): 869-872, 2001.

Mitra J, Somasundaram K, El-Diery WS, Sathyamurthy K, Herlyn M and Enders GH*. Induction of p21

(WAF1/CIP1) and inhibition of cdk2 is mediated by the tumor suppressor p16 (INK4A). Molecular and

Cellular Biology 19(5): 3916-3928, 1999.

Mitra J and Schultz RM*. Regulation of acquisition of meiotic competence in the mouse: changes in the

sub cellular localization of cdc2, cyclin b1, cdc25c and wee1, and in the concentration of these proteins

and their transcripts. Journal of Cell Science 109: 2407-2415, 1996.

Mitra J and Chowdhury M. Ca dependant activation of rat uterine glycerylphosphorylcholine diesterase:

presence of a positive modulator protein in uterine secretion. Molecular and Cellular Biochemistry

139(2):101-108, 1994.

Mitra J and Chowdhury M. Association of glycerylphosphorylcholine with human sperm and effect of

capacitation on their metabolism. Reproduction Fertility and Development 6(6): 679-685, 1994.

Mitra J and Chowdhury M. Glycerylphosphorylcholine related alterations in the oxygen consumption

profile of rat sperm in different functional states. International Journal of Andrology 15: 345-354, 1992.

Mitra J and Chowdhury M. Purification and characterization of rat uterine glycerylphosphorylcholine

(GPC) diesterase and its tissue specific induction by 17-β estradiol. Endocrinology 129(3): 1147-1154,

1991.

Mitra J and Chowdhury M. Glycerylphosphorylcholine diesterase activity of uterine fluid in conditions

inducing secondary sex ration change in the rat. Gamete Research 23(4): 415-420, 1989.

Page 4

Contact this candidate