Dr. Nandita Adhikary

Expert Medical Writer – Manager, Regulatory Writing and Submissions, Novartis Healthcare, Hyderabad, India

Mobile: +91-970*******; Email: ac61rt@r.postjobfree.com; ac61rt@r.postjobfree.com

Professional Summary

Expert Medical Writer with regulatory writing, publication writing and medico marketing writing experience for over 15 years, and a budding people manager with excellent interpersonal and communication skills, highly energetic and passionate about developing talent, skilled in building high performing teams through inspired leadership, believes in team work, continuous reflection and development for every associate.

Specialties: Sound scientific background, good analytical and logical reasoning, excellent medical writing and project management skills, multi-tasking and experience of working across therapeutic areas and a budding people manager

Core competency: Regulatory Medical Writing, Scientific & Medico marketing Writing, Domain Knowledge and Management Skills

Regulatory medical writing (Leading and drafting Module 2 eCTD documents for critical submissions including Summary of Clinical Efficacy, Summary of Clinical Safety, and Clinical Overview; time critical and submission relevant Clinical Study Reports; Addendum to Clinical Overview for renewal packages, CDS updates, Article 46, Patient Narratives, First Interpretable Results, Clinical Trials Results Database, Investigator Brochure, Briefing Book, Development Safety Update Report and Risk Management Plans)

Medical and Scientific Communication and Medico marketing Writing (Scientific and Conference Abstract, Poster, Oral presentation, Primary and Secondary Manuscript, and Review articles)

Domain Knowledge: Medical background and Therapeutic Area knowledge (Immunology, Respiratory, Dermatology, Rheumatology, Pediatrics and Woman health); Drug development process, pharmacology, drug safety; Statistics; Technical Guidelines (ICH GCP Guidelines; CONSORT; ICMJE Guidelines)

Management Skills: (Timelines Management with eye for quality including quality review, People Management – Hiring talent and quick onboarding process, Objective Setting and Review, coaching, mentoring and training, align and motivate, developing a team member, merit increase and compensation; Project Management – Workload distribution and resource planning; Customer management – managing customer and stakeholder expectations; Process excellence – development of metrics (RACI Metrics); Vendor Management including Narrative outsourcing and piloting, Vendor point of contact for QC of CSRs; Leading and contributing to team initiatives; Budget proposal and preparation of expense report; Inspection and audit readiness; Driving communication and collaboration)

Work history

Novartis Healthcare Pvt. Ltd. Hyderabad (Apr 2008 till date)

oCurrent Position and additional roles: Expert Medical Writer – Manager

Additional roles: Co-Franchise Liaison (EM Franchise), Project Medical writer, Trainer/Mentor

oEarlier Positions: Expert Medical Writer, Senior Medical Writer, Senior Scientific Writer, Publication Writer and Brand Lead

oOther roles: President of Toastmasters Club at Novartis Hyderabad (2016-2017), Immediate Past President (Club Mentor 2017-2018)

Indigenes Life systems Pvt. Ltd. (May 2006 to Apr 2008) – Associate Manager (Scientific Writing)

Passi Publications Pvt. Ltd. (Apr 2004 to May 2006) – Content Developer and Assistant Editor

Clinical Experience – Medical Practice (Apr 1997 to Mar 2004)

Education

MBBS from Lady Hardinge Medical College, New Delhi (1997)

Certifications

Project Management Body of Knowledge (PMBOK) 4th Edition Workshop by Project Management Institute Pearl City Chapter (C270), (Dec-2009)

Aspiring Leadership Program (ALP-1) by Competency Development Services (Jul-2013)

Subject Matter Experts (SMEs) Boot camp by Education Office, Switzerland (Sep-2013)

Train The Trainer by Dale Carnegie Training Institute (Oct-2013)

Step-up-to-Leadership Program by Franklin Covey Academy (Jul-2015)

Accelerated Development Program for Women in Leadership (12-Month Program) in association with IIM-Bangalore (Project with Signal Detection and Empirica Team) (2015-2016)

Toastmasters International (Leadership and Communication Program Certifications – Advance Communicator Bronze (2017) and Advance Leadership Bronze(2017))

Basic Regulatory Affairs Certificate Course (2018)

Established Medicines and Anti-Infective Learning & Assessment Board (EMAI-LAB) (2018)

Skill sets

People Management Skills (hiring & onboarding, development plan, appraisal cycles, compensation management, rewards & recognition, coaching & mentoring)

Excellent communication skills (written, verbal, presentations)

Agility and adaptability to work in Matrix environment

Capable of change management, working in ambiguity and managing paradox

Strong operational knowledge of clinical trial reporting

Swift in prioritizing and managing multiple demanding projects

Advanced knowledge and experience of global regulatory environment and process (key regulatory bodies, key documents, approval processes, and safety-reporting requirements).

Exceptional problem solving ability

Proven track record of working in matrix environment and leading global and cross-functional project teams

Personal information

Date of Birth: 06-Mar-1973

Gender: Female

Marital Status: Married

Languages known: English, Hindi, Bengali

Accomplishments at Novartis

Above and Beyond Awards

Appreciation/Applause Awards

Other Awards

RAD00H2304 Narrative Writing Project Lead (Oct 2011)

Lucentis Risk Management Plan (Apr 2012)

FCR001A2201 Clinical Study Report (Apr 2015)

Aclasta Investigator Brochure (Jan 2017)

Voltaren Addendum of Clinical Overview (Jun 2017)

AIN457A2211E1 Clinical Study Report (Sep 2017)

FTY720D2311 Clinical Study Report (Nov 2017)

Leading Aavishkaar site-wide 2018 at the site (Jul 2018)

IIS Newsletter (Oct 2012)

AIN457 DSUR Issue 3 (Oct 2013)

Conducting Aavishkaar event during Mar-2017 on behalf of Culture of Innovation site level initiative (Sep 2017)

Faculty for basic PPM (Dec 2017)

Active participation in RWS film preparation (Feb 2018)

Spot Award (Respiratory Portfolio Poster for ERS Congress) (Dec 2008)

A&B Team Award (Narrative Writing Outsourcing and Piloting) (Apr 2013)

Global Experience Program Reward for outstanding performance during year 2013 (Apr 2014)

Development Award for Exceptional Team Performance (Oct-2015)

A&B Gold Team Award (CSR Toolkit version 1) (Sep-2016)

Declaration:

I hereby declare that the information furnished above is true to the best of my knowledge.

Yours truly,

Nandita Adhikary

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