Experience

ClinScript LLC

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• President / CEO ► Independent Medical Writing | NDA Submissions | Module 2 | Vendor Management

  • 2012 - Present

  As the President and CEO of ClinScript, I lead all aspects of a full-service medical writing company — ensuring accuracy and efficiency for all deliverables. Managing a team of six seasoned writers with 40 years of cumulative regulatory medical writing experience, I help pharmaceutical and biotechnology clients with essential documentation that drives business goals. Specializations: NDA Submissions, Operational & Strategic Regulatory Writing, Module 2 Medical Writing, Drug Submissions, Medical Device writing, Quality Assurance/Control Documentation and Audits, and comprehensive Medical Communications as per client needs including Literature Reviews, Abstracts, and more. An experienced Medical Writer and Clinical Researcher, I have a solid background in Oncology, Immunology, and Genetics in the US and the EU — providing the highest quality in authoring and coordinating regulatory documents for Pharma, Medical Device and Biotech clients while achieving deliverables on time, on budget, and adhering to strict regulatory compliance. ClinScript Services: » Regulatory Writing » NDA Submissions » Medical Device CER writing as per MEDDEV 2.7/1, revision 4 and EU MDD/MDR » QC/QA and Document Audits A true full-service firm, ClinScript promotes client success with a focus on Process Improvements. This includes writing and/or reviewing medical writing SOPs, QC checklists, gap analysis, eCTD templates, starting point templates, EDMS, macro-driven templates, document audits, etc. Connect with me here for more information about the full extent of our services. You can also reach me via email: ✉ravi.pareek@clinscript.com



EMD Serono, Inc.

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Writing Lead ►Pharmaceutical Industry | Neurology/Oncology | NDA/MAA Submissions

  • Jan 2009 - Feb 2018

  As a Medical Writing Lead for EMD Serono, I was responsible for the documentation for the life cycle management of a blockbuster cancer drug. This included type II variation dossier submission for the European Medicines Agency (EMA), label change including SmpC and clinical overview 2.5 update based on RAS/KRAS/BRAF mutation screening, personalized use of the drug based on EGFR mutations. The scope of my role included overseeing all necessary medical writing activities for the clinical development for six compounds across Neurology and Oncology research. Areas of focus include: NDA/MAA Submissions, CMC formulation product registration, Briefing Documents (BD), Training, CRO Oversight, and Cross-Functional collaboration and leadership with Global Drug Safety, Medical Affairs, and Biostatistics staff, among others. Representative Highlights: » Critical team member for a Geneva-Switzerland, Darmstadt-Germany, and Rockland-USA based medical writing team for two NDA/MAA submissions —including CTD Sections 2.5, 2.7.3, and 2.7.4 as well as Module 5.3.5.3 for Integrated Safety and Efficacy Analysis (ISS/ISE); shortlisted for Merck’s Management Team of the Year » Led as a Medical Writing Trainer for 25 Medical Writers, 5 QCers, 5 eCTD Publishers in India as part of Merck’s Global outsourcing strategy » Developed comprehensive documents and provided leadership across medical writing needs for Merck — including study reports, protocols, narratives, IBs, briefing books and more while managing and ensuring timeline adherence, managing review cycles, and overseeing reports and report activities __________ EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany, employing over 1,200 individuals around the country with U.S. headquarters located in Rockland, Massachusetts. The company develops and offers therapies for specialty-care conditions, like multiple sclerosis, infertility and cancer.



Genmab

• Denmark
• Biotechnology Research
• 700 & Above Employee

• Project Manager, Clinical Operations ► Biotechnology | Team Leadership

  • Oct 2007 - Oct 2008

  Joining Genmab as a Project Manager for Clinical Operations, I managed a research team comprised of CRAs and a CTA, leading a Phase II clinical trial in Oncology. The scope of our research focused on Non-Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN) in subjects in North America and ROW encompassing 32 sites. Collaborating with strategic research partners domestically and internationally, I was responsible for the sites and countries selection, quarterly budget assumptions, Clinical Trial Agreement (CTA) and budget negotiations with sites —meeting with key opinion leaders (KOLs) and Principal Investigators (PIs). In this role, I worked with leading Oncology sites across the US. Representative Highlights: » Lead Author/Medical Writer of Clinical Development Plan (CDP), protocol, protocol amendments, ICF preparation, and initial protocol submission to FDA » Provided leadership in vendor selection and management —including CRO Central read ECG, Medical Imaging, Central lab, Genotyping, drug supply K-RAS mutation screening analysis, etc. » Project Leader along with US Clinical Director and Senior Management in Copenhagen, Denmark for a SCCHN trial (designated for Fast Track status by FDA) » Worked with Corporate Attorney on necessary legal requirements for our research— addressing issues in Clinical Trial Agreement (CTA), confidentiality and nondisclosure agreements (CDAs) and site-specific ICFs. __________ Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.



Daiichi Sankyo, Inc.

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Scientist ►Clinical Trials | CROs Management | Drug Safety | Lead Reviewer

  • Feb 2006 - Sep 2007

  In 2006, I was selected to join this innovative pharmaceutical company as a contracted Clinical Research Scientist. During my tenure here, I provided cross-functional leadership in pharmaceutical research — including reviewing clinical documents, drafting regulatory documents, ensuring regulation adherence, and working closely with the Director of Medical Writing and Global Safety. Areas of Responsibility include but were not limited to: Special Protocol Assessment (SPA), Protocol, IB CSR writing, Chemistry, Manufacturing and Controls (CMC), CROs Management, EDC, LAB Supply, DRUG supply, IVRS, and User Acceptance Test (UAT) of EDC, among others. Representative Highlights: » In charge for Investigator Brochure (IB) major annual update for Direct Factor Xa Inhibitor drug and lead person for drafting Protocol Profile (PP) —facilitating final protocol production for a large Phase III trial after Special Protocol Assessment (SPA) response from FDA » Selected as the Lead Reviewer for CSR body text and appendices i.e., end of text Tables, Figures, and Listings (TFLs) —managing and working closely with external Medical Writer and in-house CSR formatting and publishing group for final CSR production and submission » Drafted and implemented Sponsor’s Co-Monitoring plan and CRA assessment checklist using company’s SOPs; drafted CSR timelines Including 2 review cycles, QC step, formatting and final publish for CSR production from the time of TLFs availability after Data base Lock __________ Daiichi Sankyo is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets.



University of Vermont

• United States
• Higher Education
• 700 & Above Employee

• Post Doc Research Associate ► Innate Immunity | Infectious Disease | Epithelial Cell Signaling

  • Mar 2004 - Jan 2006

  As a Post Doc Research Associate at the University of Vermont, I participated in a variety of research studies related to innate immunity, infectious disease, and epithelial cell signaling. In addition, I developed multiple scientific and medical documents central to the needs of our research projects. Scope of research included but was not limited to efficacy and optimal doses of a non-clinical stage pharmaceutical compound, in-vitro genotoxicity studies, and laboratory animal research. I trained in various cell culture techniques: IHC, ELISA, Northern blot, Western blot, SDS-PAGE, PCR, and qRT-PCR. Scientific/Medical Writing and Data Management: » Performed academic writing – publication writing, grant proposals, laboratory manuals, peer review for scientific journals, book chapters, manuscripts etc. » Demonstrated ability in writing laboratory protocols — received successful approvals from the Institutional Animal Care and Use Committee (IACUC) for trial subject animals » Frequently operated with scientific graphics, spreadsheets, large datasets and plotting software in conjunction with research project needs __________ Since 1791, the University of Vermont has worked to move humankind forward. Today, UVM is a Public Ivy and top 100 research university of a perfect size; large enough to offer a breadth of ideas, resources, and opportunities, yet small enough to enable close faculty-student mentorship across all levels of study, from bachelor’s to M.D. programs.