Iram Nazish
Hyderabad
Summary
To be associated with growth-oriented industries & serve in a competitive environment allowing for effective utilisation of knowledge, experience & personal skills and strive to achieve the goals of the organization, contemplating sustained individual growth through hard work and self-improvement, in any demanding work/working conditions.
Doctorate in Pharmaceutical Sciences from Hamdard University (University topper), New Delhi with more than 11 years of experience in medical and scientific writing. Accomplished Regulatory Writer with expertise in authoring and reviewing high-quality clinical and safety documents. Delivered impactful contributions to Global Drug Development through collaboration with cross-functional teams and adherence to regulatory compliance. Focused on optimising documentation processes and ensuring timely delivery of critical documents.
Overview
21
21
years of professional experience
Work History
Regulatory Writer- Global Drug Development
Novartis healthcare Pvt. ltd
Hyderabad, Telangana
05.2020 - Current
- Working with various team of Global Drug Development E.g. Study Leader, Medical Lead, Clinical Development Director, Clinical Development Head, Clinical Program Director, Medical Information Lead, Global Medical Affairs.
- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms for various therapeutic areas such as Gastro, Immunology, Respiratory, Oncology, Ophthalmology, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, and other regulatory documents.
- Lead for e-Narrative projects. Coordinate other outsourced activities in RWS.
- Core member of Clinical Trial Team (CTT) / participate in Safety Management Team (SMT).
- Actively participate in planning of data analyses and presentation used in CSRs.
- Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May act as Program Writer ensuring adequate medical writing resources is available for assigned program and consistency between documents.
- Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
- Support the development of RWS through participating in RWS workstreams and other related activities.
- Contribute to development of processes within RWS. May contribute to cross-functional initiatives.
- Fostering cross-functional communication to optimize feedback and input towards high quality documents.
- Maintain audit, SOP and training compliance.
Medical writer/Medical Information/Scientific communication
Pharmacostats Consultancy Private Limited
07.2015 - 04.2020
- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms for various therapeutic areas such as Gastro, Immunology, Respiratory, Oncology, Ophthalmology, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, and Pop PK, SBP, SCP.
- Lead for e-Narrative projects. Coordinate other outsourced activities in RWS.
- Producing articles for publication in print and online according to agreed style, and keeping to strict deadlines.
- Manuscripts writing for Phase I to Phase IV clinical trials and BA/BE studies.
- Reviewing and amending manuscripts work.
- Write MI deliverables as well as publication writing such as Global Guidance Documents (GGDs), MI Q&As and manuscripts to ensure they meet quality requirements – scientifically balanced and evidence-based, adhere to topic/key messages, language and grammar are correct, regulatory/safety/legal aspects are considered.
- Ensure adherence to KPIs, and meet the minimum criteria in quality reviews conducted by management.
- Support the generation of reports for stakeholders on enquiry metrics and insights from countries and regions.
- Conduct MI searches for mailbox enquiries.
- Write standard and complex MI services. This can include services with a mixed model, working alongside the Senior MI Manager.
Senior Research Fellow
Indian Council Of Medical Research (ICMR)
New Delhi
01.2009 - 12.2012
- Isolated primary chemical constituents from plant extracts, advancing understanding of their potential applications.
- Conducted gas chromatography-mass spectrometry analysis of isolated oils to determine composition and quality.
- Quantification of main chemical constituent by either HPTLC/HPLC.
- Fingerprinting of main chemical constituent by HPTLC.
- Executed microscopical analysis of newly collected plant samples.
- Performed macroscopical examination of newly identified plant specimens.
- Conducted quality control assessments on newly introduced plant samples.
- Prepared comprehensive monographs on plant properties and uses to support research initiatives.
- Review of the literature (Pharmacological activities).
Lecturer-Pharmacogosy
P.D.M College of pharmacy
01.2008 - 12.2009
- Taught Pharmacology to third year students.
- Taught Biotechnology to third year students.
- Taught Pharmacology to Fourth year students.
- Taught APH to First year students.
- Taught Pharmacognosy to Fourth year students.
- Taught handling of the animals and sacrificing.
- Taught pharmacological activities of the practical related to their class.
- Muscle relaxant effect of diazepam on mice using rota – rod apparatus.
- Analgesic effect of diclofenac sodium using tail immersion method/ tramadol using hot plate method/ tramadol against acetic acid induced writhing in mice/ pentazocin in mice by tail flick method (Analgesiometer).
- Hypnotic effect of diazepam using mice.
- Mydriatic effect of atropine in rabbit eye.
- Miotic effect of Pilocarpine in rabbit eye.
- Collection of blood from rat eye.
- Dissection of Rat.
- DRC of acetylcholine using rat ileum.
Senior Pharmacist
Global Health Line Pvt. Ltd
01.2005 - 12.2006
- Dispensed medication to patients, ensuring adherence to safety guidelines and optimising patient health outcomes.
- Communicated safe use of medicine and cosmetic items to consumers, promoting informed choices and compliance with health standards.
- Managed customer complaint calls, resolving issues promptly to enhance patient satisfaction and trust.
- Management of Warehouse.
Education
Ph. D. - Pharmaceutical Sciences
Hamdard University
New Delhi06-2026
M.Pharm. - Pharmaceutical Sciences
Hamdard University
New Delhi06-2026
GATE - Pharmaceutical Science
IIT
New Delhi01-2006
B. Pharm. - Pharmaceutical Science
Hamdard University
New Delhi01-2005
Skills
- Agile learner
- Project management
- Collaboration
- Document quality
- Process navigation
- Operational efficiency
- Clinical writing
- Regulatory compliance
- Data analysis
- Cross-functional collaboration
- Scientific communication
- Quality assurance
- Technical documentation
- Creative writing
- Content writing
- Academic writing
- Grammar and spelling
- Creativity and imagination
- Self-discipline
- Research proficiency
- Review writing
- Attention to Detail
- Editing
- Proofreading
- Editing proficiency
- Narrative writing
- Proofreading documents
- Academic research
- Self-publishing experience
- Editing documents
- Copy editing
- Formatting abilities
Accomplishments
- Lifetime member of APTI
- Editor in HK College Magazine 'IMPULSE'
- Member of Research Advisory Board of HK College
- Qualified GATE-2006 (Graduate Aptitude Test for Engineers) conducted by IIT, New Delhi
- Received Senior Research Fellowship during ICMR project
- Received Senior Research Fellowship from UGC during Ph.D tenure.
- Received award in 1st, 2nd, 3rd and 4th year of Bachelor of Pharmacy for the Third ranker
- Received Several Galaxy Awards
- Received Several Star Awards
- Excellent feedback received from the local and global stakeholders of Novartis GDD.
Custom
- Syntheses and characterization of nanomaterials, organized by Indian society of Analytical scientist (ISAS) Delhi Chapter and Department of Chemistry, Jamia Hamdard, 2007-11-17
- Role of pharmacist in Safe Use of Medicine, organized by Advance Institute of Pharmacy, Palwal, Haryana, 2008-11-21
- Recent trends in Drug Development – A focus on novel drug delivery systems, organized by P.D.M College of Pharmacy, Bahadurgarh, Haryana, 2009-02-02
- Recent Advances in Drug Delivery and Design, organized by Advance Institute of Pharmacy, Palwal, Haryana, 2009-03-16
- Innovative Technologies, Research and Development in Science, Technology and Management (ICIT-09), organized by P.D.M College of Engineering in collaboration with IEEE-IMS/EMBE (Delhi), Bahadurgarh, Haryana, 2009-06-18
Languages
English
Proficient
C2
Hindi
Proficient
C2
Arabic
Beginner
A1
Interests
- Cooking
- Travelling
- Music
Personal Information
- Passport Number: M0617627
- Father's Name: Late Mohd Yaqub
Timeline
Regulatory Writer- Global Drug Development
Novartis healthcare Pvt. ltd
05.2020 - Current
Medical writer/Medical Information/Scientific communication
Pharmacostats Consultancy Private Limited
07.2015 - 04.2020
Senior Research Fellow
Indian Council Of Medical Research (ICMR)
01.2009 - 12.2012
Lecturer-Pharmacogosy
P.D.M College of pharmacy
01.2008 - 12.2009
Senior Pharmacist
Global Health Line Pvt. Ltd
01.2005 - 12.2006
Ph. D. - Pharmaceutical Sciences
Hamdard University
M.Pharm. - Pharmaceutical Sciences
Hamdard University
GATE - Pharmaceutical Science
IIT
B. Pharm. - Pharmaceutical Science
Hamdard University