Scientific Communications Consultant
Resume:
LALITHA P. CHANDRASHEKHAR
*** ******* ***, ******** *******, NJ 08853
C: 908-***-**** • ****************@*****.***
PROFESSIONAL PROFILE
Dynamic, innovative Scientific & Medical Communications Professional with over five years of pharmaceutical industry experience in regulatory affairs, scientific research, and pharmaceutical development informatics.
Professional strengths include:
- An expertise in scientific terminology and laboratory processes, allowing effective communication flow between various company divisions.
- Working within a cross-functional team to enforce strict adherence to FDA regulations and guidelines, ensuring highest level of compliance without compromising quality.
- Cultivating and maintaining strong interpersonal relationships across all organizational levels, promoting efficiency and effectiveness.
KEY SKILLS
Proficient in Medical Terminology | Excellent Scientific/Technical Communication
Internal Processes | GMP, GLP & GCP Guidelines FDA Regulations | Pharmaceutical Drug Development Process
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Working with Cross-Functional Teams | Creative & Innovative | Solution-oriented | Strong Leadership Skills
Technical & Computer Expertise | Excellent Writing & Presentation Skills | AMA Style Proficiency
EXPERIENCE
Independent Scientific Communications Consultant March 2011 – Present
Provide independent freelance medical writing and editing services for pharma projects for various clients including pharmaceutical ad agencies and life sciences firms. Primary clients include:
- A healthcare ad agency writing protocol and safety documents, copywriting and editing in the medical device area.
- A pharmaceutical ad agency doing writing work for oncology projects and interacting with advisory boards.
- A life sciences firm focusing on emotional and perceptive research doing writing, editing and project management work.
Scientific Communication & QC, Lead September 2010 – February 2011
Prescient Life Sciences, Mount Olive, New Jersey
Create comprehensive research and analytical presentations for major pharmaceutical clients. Working towards optimizing QC processes and review workflows to ensure excellence of deliverables.
- Utilized scientific writing skills to create presentations and proposals as final deliverables for pharmaceutical clients based on primary and secondary research.
- Performed an extensive review of deliverables to ensure clarity of technical and medical information; consistency of format; as well as grammar and overall syntax perfection. Approved documents and final deliverables based on internal QC requirements.
- Developed a comprehensive QC workflow across all global sites incorporating a detailed sign-off procedure.
- Performed primary and secondary research in several different therapeutic areas to contribute information to assemble reports.
- Generated detailed reports on specific therapeutic areas including oncology, HCV, and vaccines with focus on disease progression, epidemiology (including incidence and prevalence), and areas of unmet medical need.
LES Scientific Methods Expert Consultant, PDMS August 2009 – September 2010
Genzyme Corporation, Framingham, MA
As a Scientific Methods Expert for a one year contract assignment, played an integral role as the liaison between scientists/laboratory personnel and ELN development group. Successfully identified key requirements to ensure complete accuracy and compliance of written procedures.
- Developed a modified laboratory workflow after evaluating existing practices and procedures for use with the StarLIMS Electronic Laboratory Notebook (ELN) system.
- Collaborated with other teams to determine a means to harmonize Lab Execution System (LES), LIMS, Product Release Information Management System (PRIMS), and Chromatography Data System (CDS) components of global implementation project.
- Redesigned lab procedures to increase effectiveness and compatibility with the StarLIMS ELN system to allow use of electronic lab notebook for higher level of GLP and GMP maintenance.
- Performed data analysis and created documentation recording the efficacy and scientific accuracy of newly created ELN methods.
- Developed an effective verification process prior to implementation of the ELN system for scientific data analysis.
- Managed project processes for various labs at three global sites – Ridgefield, NJ; Haverhill, UK; and Lyon, France
- Utilized expertise in French language to work with Genzyme’s sites in France – Lyon and Marcy.
Scientific Application Specialist Consultant, Pharmaceutical Development Informatics June 2007 - July 2009
Bristol-Myers Squibb Company, New Brunswick, NJ
As a Scientific Application Specialist for a two year contract assignment, led the development of Velquest procedures for use in analytical, clinical
and preclinical labs at Bristol Myers-Squibb.
- Worked with scientists, lab managers, and analysts from analytical, clinical and preclinical laboratories at three different BMS sites (US and UK) to define parameters and effective workflow for lab procedures specific to each department.
- Reviewed protocol documents to ensure that departmental, safety and company standards are met.
- Redesigned lab procedures to increase effectiveness and compatibility with the specific system to allow use of electronic lab notebook for higher level of GLP and GMP maintenance.
- Performed updates to clinical study data sheets based on new study results.
- Successfully developed and implemented a system to effectively track projects within the PD Informatics department.
- Trained laboratory personnel in effective implementation of redesigned lab procedures.
Information Analyst Scientist Consultant, Merck Index Group January 2007 – March 2007
Merck and Co. Research Labs, Rahway, NJ
As an Information Analyst Scientist for a three-month contract assignment, developed chemical monographs for publication in the 15th edition of The Merck Index to reflect current scientific, medical and technological uses of compounds for most effective home or medical use.
- Researched details of various chemical compounds including the properties, and clinical and therapeutic uses by using most current scientific literature from medical journal research articles and abstracts.
Medical Regulatory Affairs Associate, Advertising and Labeling Group July 2005 – September 2006
McNeil Consumer Healthcare (Part of J&J), Fort Washington, PA
As the Regulatory Review consult, provided final review and approval of all information in major product websites, and related product collateral.
- Worked with Promotional Review Committee to review and approve various promotional and marketing materials, prior to launch, based on DDMAC processes.
- Performed regulatory review of new websites at proposal stage and in test environment prior to launch, and responsible for regulatory review and audit of existing website content.
- Created a format for organizing medical and use information of various drug products on company product website for more effective, fundamental consumer understanding.
- Created change documentation for updates to product information labels to be submitted to Information Management (IM) department to apply to current product websites.
- Performed extensive regulatory review as the OTC product expert of draft and final versions of labeling, Product Information sheets, and advertising and marketing materials for consumer and specialty products to ensure compliance with FDA requirements and regulations.
- Performed detailed review of supporting scientific documentation for marketing materials including journal articles, research materials, reports, and technical documentation; assisted in preparation of annual reports and regulatory documentation.
- Developed and coordinated the process for SPL conversion and created an effective workflow method for completing project within required timeframe.
- Interacted with cross-functional committee including members from Regulatory Affairs, Medical Information, Marketing, IT and Legal to complete projects in a timely manner.
Laboratory Technical Writer, Microbiology Quality Control March 2005 – June 2005
McNeil Consumer Healthcare (Part of J&J), Fort Washington, PA
Authored a technical report submitted to internal and federal departments for review and implementation in the Microbiology Quality Control Lab.
- Analyzed laboratory protocols, PSURs and test result data to ensure that proposed changes to procedures were in accordance with GLP/GMP guidelines, company standards, and FDA regulations.
- Performed a detailed risk assessment of proposed changes to laboratory procedures by evaluating raw material data and potential exposure to microbial agents prior to receipt in the company plant.
- Communicated with suppliers and vendors of raw materials to ensure that their processes are in compliance with industry best practices to eliminate risk of contamination with microbial agents.
- Utilized skills such as research, technical/scientific writing, and computer skills (Microsoft Office Suite and Adobe)
Academic Associate, Pediatric Emergency Department January 2005 – August 2005
Cooper University Hospital, Camden, NJ
As an Academic Associate, provided valuable insight and necessary support for two clinical research studies in the Pediatric Emergency Department.
- Worked on two research studies involving patients – fever study and smoking/respiration study.
- Completed coursework and worked with IRB regulations and clinical research methods.
- Conducted study interviews with patients and prepared informed consent documentation for patients.
- Interacted with hospital personnel at all levels – administered clinical research surveys to patients and conducted interviews, shadowed of doctors and medical students, aided nurses in tasks within the Emergency Department.
Student Researcher, Proteomics September 2003 – March 2004
Drexel University Department of Bioscience, Philadelphia, PA
Conducted valuable research by sequencing unknown gene fragments with the long term goal of creating a full scale mapping to effectively understand gene-protein interactions.
- Involved use of gel electrophoresis (protein and DNA), PCR, RACE protocol, Western Blotting, DNA extraction, protein extraction (minpreps), gene cloning and amplification, E.coli transformations, ELISA, immunofluorescence assays, immunohistochemical techniques, and HPLC.
Summer Intern, Department of Oncology Biology June 2003 – September 2003
Novartis Pharmaceuticals, East Hanover, NJ
As a summer intern in Oncology Biology, conducted research to analyze levels of HDAC expression as an indicative factor of cancer development.
- Project 1 : HDAC expression profiling in pre-cancerous and cancerous tissues
- Project 2 : Processing and analysis of clinical trial samples
- Involved the use of buffer preparation, macrodissection, protein extraction, protein purification, gel electrophoresis, Western blotting and transfer, densitometry analysis (using Odyssey software)
Independent Study Researcher, Neuroscience Department February 2003 – June 2003
Drexel University School of Medicine, Philadelphia PA
As an independent study student research project in collaboration with GlaxoSmithKline, analyzed the effects of mainstream cancer drug dosages on axonal growth and development in neuron cell samples.
- Performed data analysis of neuronal growth response to varying cancer drug dosage.
- Project performed involved a study of the effects of various cancer drugs on the growth and development of both neuronal growth as well as existing neuronal function. Quantification was performed by measuring axonal growth at various timepoints.
ACADEMIC & PROFESSIONAL DEVELOPMENT
Bachelor of Science, Bioscience & Biotechnology, Drexel University September 2002 - June 2006
Pennoni Honors College, Philadelphia, PA
- Additional concentrations in Psychology, Bioinformatics, Premed track.
- Writing and lab intensive curriculum with detailed presentations, posters and research documents.
CERTIFICATIONS
Regulatory Writing & Clinical Trial Reporting November 2010
Epidemiology & Biostatistics November 2010
Medical Writing Training (MWT) Certificate, D&D Books
SKILLS & ACCOMPLISHMENTS
TECHNICAL & SCIENTIFIC
- Protein Chemistry: Harvesting from cells and tissues, Western Blotting, densitometry analysis, HPLC, enzyme purification, Bradford Assay, mass spectrometry
- Microbiology: Soil & water testing, Winogradsky analysis, gram staining, isolation streaking, organism isolation
- Molecular Biology: DNA fingerprinting and extraction, electrophoresis, southern blotting, nucleic acid hybridization, replica plating, PCR (including RACE protocol), cloning and transformations, restriction digestion methods and mapping, staining methods, immunoprecipitation, immunofluorescence, cytochemistry, Cell/Tissue Culture – Growth/maintenance of cell lines, culture methods
- Bioinformatics: NCBI databases- BLAST, OMIM, PubMED, Homologene
- Chemistry: Thin-layer Chromatography methods, dehydration of alcohols, oxidation reactions, Grignard Synthesis, Enamine Synthesis, and Aldol Condensation
LANGUAGES
Telugu | Hindi | French | Latin
COMPUTER SKILLS
Microsoft Office Suite – Word, Excel, Project, Frontpage, Powerpoint | Electronic Document Management System (eDMS)
MATLAB | Visual Studio .NET | SAS | Adobe Suite | Bioinformatics tools/databases | Velquest Smartlab | Aegis Pro | StarLIMS
- www.linkedin.com/in/lpchandrashekhar -
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