Meet Our Instructors
Sharon Barattini has over 30 years of experience in Contract Research Organizations (CRO) supporting pharmaceutical research and aerospace and defense industries. She is currently a Senior Quality and Compliance Specialist at MMS Holdings Inc. She holds a Bachelor of Science in Chemistry from the State University of New York (SUNY) College at Oswego.
Barattini has supported bioanalytical method development, validation, and analysis using mass spectrometry. She has over 25 years of experience in Quality Assurance and Quality Control of studies under GLP, GCLP, and GMP requirements. In addition, she has served as an SME in training, Document Control, and QMS development initiatives.
Dr. Teresa Ceseña
Dr. Teresa Ceseña has over 10 years of pharmaceutical writing experience, and now leads the medical writing department as Senior manager of medical and regulatory writing since 2009. The medical writing team has grown significantly, and one of her key responsibilities has been to ensure that onboarding, training and mentoring continue to maintain high levels of quality. Before coming to MMS, she had also taught at the university level.
As one of her key responsibilities is training of new medical writing colleagues, Dr. Cesena is responsible for implementing and maintaining processes and training programs. This includes establishing training exercises, other training material, and the development and training of mentors. Other responsibilities include developing training material for clients.
In addition, she has successfully led multiple and complex regulatory writing documents, and that experience has been applied in the MMS training programs. Her document repertoire includes, but is not limited to:
- Large, complex submissions, including safety and efficacy documents
- Clinical Study Protocols
- Clinical Study Reports
- Lay summaries
- Briefing Documents
- Writing and submitting grants, including facilitating grant writing workshops
Pallavi Dua has over 13 years of Industry experience in Case Management (Global Clinical Trial and Post Marketing) experience in the healthcare and Pharmacovigilance domain. She currently works as a Senior Manager for the Pharmacovigilance operation Team at MMS Holdings Inc. She holds a Bachelor of Dental Surgery from B R Ambedkar University, Agra, and completed a Diploma course in Clinical Research.
Her primary areas of focus include team management (Global and Multi-hub) in accordance with organization policies, handling multiple clinical trials projects and multiple safety databases, Automation, Coding/Labelling, Reporting & Documentation, SOP/WP/GD, Data Management, Clinical Research and Documentation, Project Management, Transition and Implementation of projects, CAPA Management and Process improvements initiatives. Her key responsibilities at MMS include diverse work force management, providing technical guidance to the team, operations, and training of safety reviewers on various safety documents. She enjoys new challenges and continuous development.
Monique Goldblatt, MS
Monique Goldblatt has worked as a Medical Writer in the pharmaceutical industry for 13 years, working in several Clinical Research Organizations and a Pharmaceutical Company. She is involved in many initiatives within MMS and enjoys sharing her knowledge that she has gained during her career. She continues to develop her skills in the industry by ensuring that each project is a challenge better than the previous one.
Chris Hurley, MBA
Chris Hurley has worked in the industry since 1990, starting as a contract SAS programmer in the Clinical Data Management department at Warner Lambert/Parke-Davis, which later was acquired by Pfizer. At Pfizer, Chris moved to Clinical Reporting Systems where he worked on statistical programming and data standards projects.
In 2007, Chris started working on the CRO side of the business where he spent three years at i3 Statprobe, in Ann Arbor. Since 2010, Chris has been manager of Clinical Programming and Biostatisticians at MMS Holdings Inc., Canton, Michigan, USA. Chris has supported many statistical programming projects at major pharmaceutical companies. Chris has also provided leadership support as was evident when he was assigned to help develop a data anonymization solution for a major pharma company. Together, with a small team from the sponsor and MMS Holdings, Chris helped develop global standards, SOPs, software and validation for this important initiative.
Chris started volunteering for PHUSE in 2013 as a co-chair for a Single Day Event (SDE). In 2014, Chris stepped up to contribute as US Events Project Co-Lead where he helped plan and organize all US PHUSE SDEs. In 2015, Chris was added to the PHUSE Board as Director of US Events. In 2016, Chris assumed more responsibilities on the board in his current role as PHUSE Americas Director.
Senthil Kumar, MBA
Senthil Kumar is a Manager in the Department of Statistical Programming at MMS. He obtained his MBA from Sathyabama University, Chennai and his BE from Bharathidasan University, Trichy. He has over 12 years of professional experience, including central nervous system, cardiovascular, Psoriasis, Major Depressive Disorder, SDTM, ADAM & TFL programming. His area of expertise is in NDA submission, and he has contributed as a programmer, reviewer, SME, and trainer in the various stages of his career. Kumar has been actively involved in recruitment, on boarding, training, resourcing, project management, and line management of staff.
Dr. Margaryta Mare
Margaryta Mare is a Medical Director in Drug Safety and Pharmacovigilance at MMS in South Africa. She had over nine years of clinical experience as an MD before moving to clinical research in 2005. Mare has more than 15 years of experience in pharmacovigilance and medical affairs. In addition, she has worked with a cross-functional team and controlled entire medical monitoring and pharmacovigilance services in more than 50 international clinical trials. Mare also holds an MD from Kharkiv National Medical University.
Kasim McLain is Manager of Transparency at MMS and has worked in the area of Transparency for more than 10 years. Kasim has managed all aspects of clinical trial disclosures at both Sponsor companies and CROs and is now helping Sponsors produce quality deliverables, understand industry best practices, and develop their processes and procedures. Kasim is passionate about Transparency and values returning clinical trial data to trial participants so that they can make informed decisions regarding their healthcare. She enjoys mentoring and sharing her knowledge with colleagues new to the space.
Jennifer Perrin has over 20 years of experience in regulated industries such as pharmaceuticals, medical devices, and Active Pharmaceutical Ingredient (API) manufacturing. Jennifer is a Manager of the Quality and Compliance Team at MMS Holdings Inc., and she holds a Bachelor of Science in Psychology from Cleveland State University.
Perrin has supported multiple clients in developing, maintaining, and inspecting Quality Management Systems (QMS). She also has experience in working with multiple global health authorities such as FDA (US), ANVISA (Brazil), and EMA (EU). In addition, her auditing expertise includes vendor, investigator site, and Chemistry and Manufacturing Controls (CMC) audits. She also has experience with writing CMC portions of regulatory submissions and annual reports. Her GxP regulation knowledge includes Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP). Her key responsibilities at MMS include work-force management, providing technical guidance to the team, audit, and client project oversight.
Tejaswini Kaipu Ravindranath, MS
Tejaswini Ravindranath currently works as a Senior Medical Writer at MMS Holdings Inc and has over seven years of experience in scientific, medical, and regulatory writing for the Clinical Research and Pharmaceutical industries. She holds a Master of Science in Biotechnology from Kuvempu University and a Bachelor of Science in Biology (Zoology) from Mount Carmel College Bangalore. In addition, she has completed a PG Diploma course in Clinical Research from ICBIO, Bangalore.
Ravindranath has supported multiple new drug approval submissions for critical diseases to global health authorities such as FDA (US) and EMA (EU). Her regulatory document expertise includes writing and supporting clinical study reports, protocols, informed consent forms, clinical efficacy and safety summaries, and investigator brochures. Her key responsibilities at MMS include mentoring the new colleagues and training writers on various regulatory documents. She enjoys mentoring new medical writers and has developed and conducted many document-specific training exercises.
Susmita Sahu, MS
Susmita Sahu has over 12 years of experience in scientific, medical, and regulatory writing for the clinical research and pharmaceutical industries and is a Senior Manager of medical writing at MMS Holdings Inc. She holds a Master of Science in Biotechnology from Bangalore University and a Bachelor of Science in Biology (Zoology) from Utkal University.
Susmita has supported multiple new drug approval submissions for critical diseases to global health authorities such as FDA (US) and EMA (EU). Her regulatory document expertise includes writing clinical study reports, protocols, informed consent forms, clinical efficacy and safety summaries, non-clinical summaries, and investigator brochures. Her key responsibilities at MMS include diverse workforce management, providing technical guidance to the team, and training writers on various regulatory documents. She enjoys mentoring new medical writers and has developed many document-specific training exercises.
Saichand Satyavarapu has over 12 years of experience supporting the pharmaceutical industry as a Statistical Programmer. Satyavarapu has worked in various roles at MMS, and he currently holds the title of Manager of Statistical Programming for MMS. Under his leadership, the Statistical Programming team has grown significantly. One of his key responsibilities has been to ensure that onboarding, training, and mentoring for statistical programming continue to maintain high levels of quality at both the Bangalore and Hyderabad locations.
He has performed extensive SAS programming activities throughout his career to support both study and submission level tasks, including utilization and application of SDTM and ADaM CDISC standards. Satyavarapu has worked on various therapeutics such as CNS, Dermatology, Ophthalmology, and Rheumatology throughout his career. Satyavarapu has contributed to programming standards to maximize efficiencies, which included the development of global macros. He holds a PGCRCDM (Post Graduation in Clinical Research and Clinical Data Management) from Goa University.
Dr. Arunima Sen
Dr. Arunima Sen is the Director of Pharmacovigilance and medical writing for MMS, India. She is an MD by qualification, a certified MedDRA coder, and has over 15 years of experience as a Pharmaceutical Physician. Prior to MMS, she was associated with AstraZeneca Pharmaceuticals and served as a clinical trainer in Kasturba Medical College, Manipal, Karnataka.
At MMS, Dr. Sen has trained and mentored Pharmacovigilance colleagues through the years and led and contributed to various successful projects globally across different safety writing documents, aggregate reports, medical coding, safety surveillance, among others.
Kavita Verma, MSc
Kavita Verma is a Senior Transparency Lead at MMS Holdings with over 14 years of experience working in the pharmaceutical industry, operating as a regulatory lead, managing outsourced business to CROs, and working within CROs handling multiple clients. In her role at MMS, Kavita has managed clinical trial disclosure on global registries and data transparency under various global regulations. She appreciates that regulations are the key to enforcing transparency and enjoys the challenges that come with interpreting newer global regulations and implementing processes to comply with them. Kavita enjoys sharing her knowledge of transparency and learning from others.
Dr. Amina Wofford
Amina Wofford has over 10 years of scientific and regulatory writing experience as a graduate student, post-doctoral fellow, and Medical Writer. Dr. Wofford is a Medical Writer at MMS Holdings Inc. She holds a Bachelor of Science in Biology from Tuskegee University, a Master of Science in Human Environmental Sciences from The University of Alabama, and a Doctorate of Philosophy in Integrative Bioscience from Tuskegee University.
Dr. Wofford, in different capacities, supports various IND applications for submission to global health authorities (e.g., FDA, EMA). Her regulatory document experience includes protocol amendments, investigational brochures (IB), Informed Consent Forms (ICF), and clinical summary modules. Her key responsibilities at MMS include working with Sponsors to ensure consistent, high-quality documents are delivered according to timelines and contributing to Medical Writer engagement by co-facilitating Medical Writer staff meetings and serving as Training Committee member.
FROM OUR FOUNDER
“Our goal is to provide a real-world, credible and reliable learning experience that allows students to gain subject matter expertise and to strengthen their skill sets to become more competitive in their chosen field of work.”
Uma Sharma, PhD
Chief Scientific Officer at MMS