2022 年 6 月 8 日 – 11am ET
Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry?
Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory).
Our team is growing, and we’re looking for people with strong scientific backgrounds who are passionate about our mission to accelerate developing medicines for patients while furthering their career growth.
Join the Regulatory and Medical writing experts from Certara as we discuss their career paths and what it’s really like to be a writer in this dynamic and exciting industry!
Attend this interactive LinkedIn Live event to learn:
- How to best position yourself to be competitive in the reg/medical writing industry
- How Certara supports the professional development of our writers
- About our Regulatory Writer Acceleration Residency (RWAR) a mentor-driven training program that accelerates the transition to leading the writing efforts for regulatory documents
You will also have the opportunity to ask our panel of experts questions during the event.
Ms. Graham has more than 15 years of experience in Medical Writing and Regulatory Strategy across multiple therapeutic areas, including orphan drugs and rare diseases. She has authored submissions and led regulatory strategy for global health authorities including FDA, Health Canada, PMDA, TGA, MHRA, and EMA. Ms. Graham was the Global Head of Medical Writing at Roche for five years prior to joining Certara-Synchrogenix as the Vice President Regulatory Writing and Scientific Publications in late 2021. She is a certified Executive and Life Coach with a passion for people-centered leadership and focuses her career on incorporation of patient-centered measures in regulatory content and decision making.
Mr. Meats is an associate director of regulatory medical writing with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in clinical protocols, all CSR types, lay/plain language summaries, IBs, NDA and IND clinical modules, regulatory responses, 4-month safety updates, and pharmacovigilance documents. David has been a submission writing leader on several compounds across numerous regulatory agencies. He is the co-chair of the US DIA conference for medical writing and scientific communication.
Ms. Binns has over 20 years of experience in clinical research, pharmaceutical drug development, clinical diagnostic care, and regulatory writing. Her therapeutic areas of expertise include neuroscience, central nervous system and neurodegenerative disorders, pulmonary and sleep medicine, pediatrics, infectious disease, oncology, and autoimmune disorders. Ms. Binns has contributed to the development of Phase I and II clinical trials, authored a variety of regulatory documents, and provided guidance and consulting across the drug development process. She possesses extensive client/program leadership experience to function as a bridge between client engagements/process and the optimization of best business practices.
Dr. Akins has over 20 years of experience conducting and communicating scientific studies, primarily in academia until transitioning to regulatory writing in 2021. He is a broadly trained biologist who has worked across a variety of therapeutic areas including CNS disorders, oncology, and cardiovascular disease and treatments ranging from small molecules to cell-based therapies. He now provides regulatory writing services focused on preclinical research pharmacology, pharmacokinetics, and toxicology in study-level and regulatory submission-level documents for INDs, NDAs, and BLAs.
Linda Tabas is the Director, Medical Publications and Communications at Certara. Ms. Tabas brings more than 30 years of experience in the pharmaceutical industry. She holds a bachelor’s degree in biology from Northwestern University.
Dr. Cleverley has more than 20 years’ experience in medical communications, which she entered shortly after earning her PhD in Microbiology and Molecular Genetics as a joint degree from Rutgers and UMDNJ, and publishing on the “glycine hinge”. She has experience in writing regulatory documents, as well as ushering these through the review process to approval and publishing with strong client lead capabilities. She has contributed editorial support for publications for prestigious higher tier journals such as NEJM and JCO, has developed digital interactive education programs, has written award-winning patient literature, and has been involved in the creation of clinical trial materials. Dr. Cleverley has been an active team member of AMWA, ISMPP, DIA, and MAPS, and has been an adjunct professor for several colleges and universities.