Nisha Kahair Manager Development Consulting & Scientific Affairs

1.Executive Summary / Key Competencies

Six sigma Green belt certified with 12 years of experience in medical, regulatory and scientific writing including CSRs and CSPs (Phase I to IV), CO and NCOs, medico-marketing materials, slide decks, BA/BE reports, eCTD.

Writing and reviewing of global dossiers/documents written for FDA, EMA and Health Canada

Strong communication skills, planning, prompt responses, result oriented, quality and customer-centric, proactive, enthusiastic and strong problem solving skills

Clinical research specialist

2.Professional Career

Since 09/2017 - today

Manager-Development Consulting & Scientific Affairs, PharmaLex India Pvt. Ltd., New Delhi, India

Preparation and review of pre-clinical sections of the marketing authorisation dossier

Preparation and review of clinical sections of the marketing authorisation dossier

Preparation and review of preclinical and clinical expert statements.

Preparation and review of clinical study reports

Handling of response phases during a marketing authorisation procedure

Preparation of the informative texts (SmPC, PIL, Labelling) of the marketing authorisation dossier

Preparation of further preclinical and clinical documents relating to marketing authorisation of a medicinal product (e.g. applications for orphan medicinal product designations, environmental risk assessments, paediatric investigation plans)

Preparation and review of other medical-scientific documents (e.g. publications, product rationales, medico-marketing material, slide-deck)

Any other reasonable tasks that are corresponding to abilities, if asked.

Since 09/2016 – 09/2017

Assistant Manager-Development Consulting & Scientific Affairs, PharmaLex India Pvt. Ltd., New Delhi, India

Preparation and review of pre-clinical sections of the marketing authorisation dossier

Preparation and review of clinical sections of the marketing authorisation dossier

Preparation and review of preclinical and clinical expert statements.

Handling of response phases during a marketing authorisation procedure

Preparation of the informative texts (SmPC, PIL, Labelling) of the marketing authorisation dossier

Preparation of further preclinical and clinical documents relating to marketing authorisation of a medicinal product (e.g. applications for orphan medicinal product designations, environmental risk assessments, paediatric investigation plans)

Preparation and review of other medical-scientific documents (e.g. publications, product rationales, medico-marketing material)

Any other reasonable tasks that are corresponding to abilities, if asked.

11/2013 - 10/2016

Assistant Manager-Scientific Affairs, JSS Research Limited, Faridabad, India

Preparation and review of clinical study reports

Preparation and review of clinical study protocols

Preparation and review of informed consent documents, case report forms, questionnaires.

Preparation and review of safety narratives

Preparation and review of eCTD (Module 5)

Assisting Managers in writing manuscripts, review articles and other commercial documents

Handling of response phases during a marketing authorisation procedure

Preparation and review of other regulatory documents (e.g. clinical study reports for devices, registry studies, observational studies, survey reports)

Any other reasonable tasks that are corresponding to abilities, if asked.

07/2010 - 11/2013

Medical Writer-II-Scientific Affairs, Jubilant Clinsys Limited, Noida, India

Preparation and review of bioavailability/bioequivalence and clinical study reports

Preparation and review of bioavailability/bioequivalence clinical study protocols

Preparation and review of bioavailability/bioequivalence informed consent documents

Preparation and review of clinical and non-clinical overviews

Preparation and review of clinical and non-clinical summaries

Preparation and review of eCTD (Module 5)

Assisting Managers in writing various regulatory documents (e.g. clinical study reports for devices, registry studies, observational studies, survey reports)

Any other reasonable tasks that are corresponding to abilities, if asked.

07/2007 - 07/2010

Research Officer-Medical Writing, Fortis Clinical Research Limited, Faridabad, India

Preparation and review of bioavailability/bioequivalence study reports

Preparation and review of bioavailability/bioequivalence study protocols

Preparation and review of bioanalytical reports

Preparation and review of method validation reports

Preparation and review of individual safety narratives

Preparation and review of electronic Common Technical Documents (Module 5)

Any other reasonable tasks that are corresponding to abilities, if asked.

06/2005 - 02/2006

Trainee executive- Sales & Marketing (All India Institutes of Medical Sciences), Baxter, India

Positioning of the Brand in the leading corporate & Government Hospitals (AIIMS)

Conduct Survey and Seminars in Various Private & Government Hospitals

Multiple Lead generation

Meeting the Junior, Sr. Doctors and HODs in various departments of AIIMS

Introduction of infusors (for pain management) in haematology department of AIIMS

Giving the Presentation on the Specialized Products (infusors, viaflex bags, pain management products) to doctors and nursing staff in AIIMS

Manufacturing exposure included insights to production, quality, purchase and warehousing

Exposure to tender submission in AIIMS for multiple medical products

3.Professional Education

Sikkim Manipal University, Manipal, India – Masters in Clinical Research and Regulatory Affairs – 2012 - 2014

Institute of Computational Biology, Bangalore, India – Post Graduate Diploma in Clinical Research and Data management – 2009

Pune University, Maharashtra, India – Bachelors in Pharmacy – 2001-2005

4.Awards

Star of the Month, JSS Research Limited, Faridabad, India August 2015

Employee of the Month-Global, Jubilant Clinsys Limited, Noida, India, March 2013

Awarded LSS Green Belt certification, Jubilant Clinsys Limited, Noida, India, April 2013

On Spot recognition award, Jubilant Clinsys Limited, Noida, India, February 2012

Contact this candidate