Senior Director, Global Medical Affairs Leader, Neuroscience, at Johnson and Johnson
Greater New York City Area
The Janssen Pharmaceutical Companies of Johnson & Johnson
Senior Director, Global Medical Affairs Leader, Neuroscience
April 2015 to Present
RB
Global Head of Clinical Development (INDIVIOR Pharma)
November 2014 to March 2015
Forest Laboratories
Director of Clinical Development
September 2011 to October 2014
FDA
Senior Medical Officer Reviewer
January 2009 to September 2011
Pinnacle Behavioral Health
President and CEO
2005 to January 2011
Philadelphia pa
Drexel University College of Medicine
March 2005 to December 2007
What company does Maju DPM. work for?
Maju DPM. works for The Janssen Pharmaceutical Companies of Johnson & Johnson
What is Maju DPM.'s role at The Janssen Pharmaceutical Companies of Johnson & Johnson?
Maju DPM. is Senior Director, Global Medical Affairs Leader, Neuroscience
What industry does Maju DPM. work in?
Maju DPM. works in the Pharmaceuticals industry.
Who are Maju DPM.'s colleagues?
Maju DPM.'s colleagues are Khvedchin Yuri, Tatiana Marante, Jesper Riise, Taina Brix, charlotte saabye elmstrøm, Crystal Henderson, Jaime Berrios, Shanaz Iqbal, Sara Derballa, and Claudia White
📖 Summary
Board Certified Psychiatrist with extensive experience in Drug Development, Medical Affairs and Regulatory Affairs. Currently functioning as Global Medical Affairs Leader for Neuroscience at Janssen Pharma. Previously was Global Head of Clinical Development at Reckitt Benckiser Pharmaceuticals, and Director of Clinical Development at Forest. Also worked as a Senior Medical Officer Reviewer in the Division of Psychiatry products at the US FDA. Have functioned as lead in drug development and medical affairs in schizophrenia, depression, bipolar disorder and anxiety. Experienced in all phases of drug development from Phase 1-4. Experience working with global regulatory agencies while applying for MA in different countries. Clinical/Medical lead for over six NDA's (ISS, ISE, SCE & SCS), PPSR, labeling updates, Briefing books, Protocol development and monitoring clinical trials. Liaising with marketing, commercial and medical affairs in ensuring that the product remains a vibrant brand. Medical affairs role for marketed products, including leading multiple product launches, KOL relationships, publication strategy, interactions with commercial, DTC advertising strategy, product positioning etc. At the FDA, was involved with many NDA, IND, safety and labeling reviews. Also authored Written Requests. Maintain strong, well established, professional working relationships at FDA. Extensive FDA and Industry based experience with all types of FDA/Industry Meetings - Type A, B & C (pre-IND, pre-NDA, End of Phase II) – including Advisory Committee Meetings, Clinical Hold Meetings and pre-approval Labeling Negotiations. Specialties: NDA and IND reviews Writing NDA and IND Protocol Development Writing PPSR and WR Safety Reviews Labeling reviews/negotiations Type A, B, & C Meetings with the FDA Design and Conduct of Clinical Trials Interpreting DataSenior Director, Global Medical Affairs Leader, Neuroscience @ From April 2015 to Present (9 months) Global Head of Clinical Development (INDIVIOR Pharma) @ Global Head of Clinical development with oversight of clinical development, clinical operations, HEOR and data management. From November 2014 to March 2015 (5 months) Director of Clinical Development @ Drug Development- CNS From September 2011 to October 2014 (3 years 2 months) Senior Medical Officer Reviewer @ Reviews of NDA, INDs, Safety, Labeling reviews, Industry meetings. From January 2009 to September 2011 (2 years 9 months) President and CEO @ Psychiatrist From 2005 to January 2011 (6 years) Drexel University College of Medicine @ Assistant professor-Psychiatry From March 2005 to December 2007 (2 years 10 months) MBBS, Medicine @ Government Medical College Bellary From 1989 to 1995 Kendriya Vidyalaya From 1980 to 1989 MD, Psychiatry @ Drexel University College of Medicine Maju DPM. is skilled in: Drug Development, Regulatory Affairs, Psychiatry, Clinical Development, FDA, Clinical Research, Clinical Trials, Pharmacovigilance, Neuroscience, Pharmaceuticals, Clinical, GCP, Regulatory Submissions, Life Sciences, Protocol Development
Extraversion (E), Sensing (S), Feeling (F), Judging (J)
2 year(s), 7 month(s)
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There's 91% chance that Maju DPM. is seeking for new opportunities
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