Medical Writer/ Regulatory Writer

Neha Lodaya

** ***** ***, **** *-*, Cambridge, MA 02138

Tel # 857-***-**** Email: **********@*****.***

Highly qualified medical writer with clinical pharmacy background and seven years of relevant work experience. Recently graduated with an MS in Epidemiology adding analytical, quantitative and statistical skills to the profile that enhance expertise in medical writing and contribute to the creation of robust and impactful clinical documents. My writing experience has been regulatory-focused, safety-focused and marketing-focused. Adept at distilling dense data into clear, concise content with logical organization. Excellent skills of collaboration with cross-functional teams & external stakeholders and manage all aspects of medical writing processes not limited to planning, developing, editing and reviewing high-quality documents within timelines, under minimal supervision. Authorized to work in the US.

Medical Writer in Phase I-III clinical trials, Bioavailability-Bioequivalence studies (for generic drugs) and Post-marketing/ Pharmacovigilance studies

Written documents for regulatory submissions to US FDA, European Union Regulatory, Ministry of Health - Turkey and DCG (I), India; Excellent understanding of ICH, GCP, ICMJE guidelines and CTD structure

Experienced in literature search & writing in Oncology, Respiratory and Neurology therapeutic areas as well as Animal Health

Work Experience

Freelance Medical Writer (June 2016 - Present)

Remote position, Cambridge, MA

Working as a freelance medical writer for Orion Corporation, writing & performing quality control of documents like clinical study protocols and study reports written at Orion

FinOrion India Private Limited, Subsidiary of Orion Corporation

Mumbai, India

Orion is a globally operating Finnish company that develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests.

Executive Medical Writer, October 2012-June 2014 (Resigned to pursue MS in Epidemiology in the US)

Writing Phase I-III clinical study protocols, clinical study reports using tables, listings, and figures, Compilation of report appendices and Compiling/editing Investigator’s Brochure (IBs) for Respiratory, Oncology and Neurology therapeutic areas and Animal health

Writing Individual Case Safety Reports (ICSRs)

Performing Quality Control of clinical documents including statistical sections, data tables & listings using documented version control and Conduct & lead comment resolution team meetings

Update & maintain medical writing SOPs, work instructions, style guide and document templates

Writing primary manuscripts and presentation materials to support the Medical Affairs and Global Sales team at Orion

Serve as subject matter expert for clinical documents and their production

Develop timelines for projects, act as point-of-contact for sponsors, internal departments & Represent medical writing team on project team meetings

Hiring, training & mentoring of newly hired medical writers

Reliance Life Sciences Pvt. Ltd.

Mumbai, India

Reliance Life Sciences is part of the Promoter Group of Reliance Industries Limited and was established to develop business opportunities in medical biotechnology with key initiatives in biopharmaceuticals, pharmaceuticals, regenerative medicine, clinical research and molecular diagnostics.

Medical Writer within Clinical Operations, July 2011- October 2012

Manage the writing process including development of documents, review process, maintaining draft versions and coordinating review and approval of final draft

Extensive writing experience of the following documents for submissions to US FDA, EMA, Ministry of Health Turkey and DCG (I) with similar timelines, maintaining excellent quality of work throughout:

Protocols and Clinical Study Reports for Phase-III Trials (Breast cancer, non-Hodgkin’s lymphoma & metastatic colorectal cancer) and BA-BE studies

Periodic Safety Update Report (PSUR), Medical Safety and Monitoring Plan (MSMP)

IBs/ Package Inserts, Case Report Form (CRF)/ Informed Consent Form (ICF)

Clinical Overviews & Clinical Summaries section from raw data in Common Technical Document

QC (technical and language), formatting and proofreading of all the above-mentioned documents

Assist business development by preparing quotes for upcoming clinical studies & bid proposals

Cognizant Technology Solutions

Mumbai, India

Cognizant is a global provider of consulting, information technology, business process services as well as outsourced solutions across industries including top global pharmaceutical companies.

Safety Data Analyst/ Safety Writer, Pfizer US Pharmacovigilance, September 2007 – July 2009

Accurately document Adverse Events (AE) on MedWatch/Adverse Event Monitoring forms, Identification of serious adverse events (SAE) and writing case narratives - Individual Case Safety Reports (ICSRs) for submission to US FDA

Academic Experience

Drexel University, Dornsife School of Public Health, Department of Epidemiology and Biostatistics

Philadelphia, PA

Research Assistant, October 2014 –May2016

Created statistical analysis for a major grant writing project under the direction of Dr. Seth Welles

Written epidemiological reports as a part of grant writing

Assisted with a study on Injection Drug Users (IDUs) in collaboration with the Prevention Point Philadelphia

Drexel University, Center for Hunger-Free Communities

Philadelphia, PA

Research Assistant, (Data Analysis, Biostatistics & Writing) June 2015-March 2016

Complete data analysis using biostatistical methods for Dr. Mariana Chilton

Conduct primary data analysis (using SAS) and communicate results in the form of Tables, Graphs, and Reports for the Building Wealth & Health Network Project, one of the major initiatives of the Center for Hunger-free Communities

Education

Drexel University, Dornsife School of Public Health, Philadelphia, PA

MS in Epidemiology, June 2016

GPA 3.83

Thesis: Psychiatric & Nervous System Adverse Events associated with Varenicline - A post-marketing data evaluation in the US

NMIMS University, Mumbai, India

MS in Clinical Pharmacy, 2011

GPA 3.74

Thesis: Profile of Opportunistic Infections in HIV patients on Highly Active Anti-Retroviral Therapy (HAART) and their associated Quality of Life

Pune University, Mumbai, India

BS in Pharmacy, 2007

GPA 3.94

Skills

Microsoft Office (Word, Excel, Powerpoint, Visio) – Proficient

SAS – Intermediate

EndNote – Intermediate

Strong attention-to-detail

Experienced in working in a fast-paced environment, handling multiple projects with similar timelines maintaining best quality throughout

Team Player & Individual Contributor; Effective liaison with various clinical units for optimal understanding and planning

Awards & Scholarships

Department of Epidemiology & Biostatistics Research Award recipient, Dornsife School of Public Health, Drexel University (2014-2016)

Awarded a scholarship and gold medal for securing first place in Masters in Pharmacy (2010)

Awarded the Best Outgoing Student for Bachelors in Pharmacy (2007)

Received the Sir Ratan Tata Scholarship towards partial funding of Bachelors in Pharmacy (2006)

Conferences and Presentations

Participated in the European Medical Writer Association (EMWA) Conference held in Barcelona, Spain as an Industry Delegate (2013)

Conducted training on “Safety Reporting - Post Marketing: Global Practices” for Clinical Research Business Group, Reliance Life Sciences (2011)

Attended the IDMA-BMJ-Hinduja Hospital Collaborative Workshop on Medical Writing – Attaining Global Insight (2010)

Writing Samples & References

Will be provided on request

Contact this candidate