Email: firstname.lastname@example.org Cell: +91-970*******
Pullareddy’s qualifications beckoned to scale up to diverse levels ranging from clinical research operations to Regulatory Medical Writing/Disclosures.
Senior disclosure specialist with ~6.5 years of progressive experience throughout the pharmaceutical and medical device industries, with specific expertise in disclosures for 4+ years, clinical research and medical writing for ~2.5 years. Worked on different documents and diversified therapy areas.
- Expert in preparation and reviewing of clinical trial application submission packages.
- Subject matter expert in protocol and basic results posting on clinical trial registries (clinicaltrials.gov, EudraCT, DIMDI, CTRI, SLCTR, PACTR and other local registries) having authored and reviewed a significant number of studies.
- Expert reviewer in quality check of the redacted CSR and ensure that CCI & PPD information is redacted.
- Successfully handled multiple client projects (worked with 3 out of top 10 pharma companies as well as small size companies) with expertise and innovative approach. A legacy of successful client projects maintained through years of trust and confidence
- Knowledge on US and EU drug and device regulations
Vast experience of document types such as clinical trial summaries (Protocol, results, and Lay summaries), documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries, PSUR's, HA response documents, protocol and results summaries to support clinical trial disclosure commitments.
Excellent written and oral communication skills, capability to professionally plan and conduct technical presentations, and Instructor-led workshops.
A strong motivator and leader with effective leadership, communication, decision making, problem solving and interpersonal skills, together with a corporate focus and a results-driven attitude.
AREA OF EXPERTISE : Clinical trial disclosure, Clinical trial applications, Regulatory medical writing, People Development, Budgeting, Resource forecasting, Instructor led training's, day to day client interface, process improvements etc...
Senior Scientific Writer Associate Indegene Apr 2017 – Till date
Leading a team of 5 members, recipient of best performer award thrice in the span of 7 months.
Initiate start-up meeting with the study team related to the creation and development of the clinical document for regulatory submission
Authoring and reviewing of pertinent regulatory documents such as: Protocol registration form (PRF) and results registration form (RRF) to support clinical trial disclosure commitments
Preparation and reviewing of clinical trial application (CTA) submission packages for pharmaceutical drugs, vaccines, GMO’s and biological products
Preparation and reviewing of cover letter for initial and amendment submissions
Preparation and reviewing of comparison tables for regulatory submission
Preparation of substantial amendment notification forms and end of trial notification forms for regulatory submission
Expert in GRAIL, CTMS, ERIS (document management tools)
Expert in disclosure tools like PharmaCM, PRS tool, VCTR
Creates and manages the Dossier Plan/Submission Packages in line with regulatory strategy. Seeks input from regulatory therapeutic areas, functional area representatives, and key stakeholders. Provides guidance to project team members
Interacting with clients and follow up till final submission
Identify and design training programs for team members
Supporting the manager in work allocation and provides oversight to team members in execution of their project responsibilities.
Ensuring timely registration of Protocols and results on Clinicaltrials.gov, EudraCT, CTRI and other National registries, etc
To prepare team for Audit ready with updated regulatory guidelines, process and to prepare audit response report
Conducting regular client calls for content-related discussions as well as for project status updates and delivery
Expert in reviewing regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc and delivers to client
Maintaining project trackers; coordination and collation of team inputs; monthly accruals and invoicing on routine basis
Mentoring of new joiners with respect to internal SOPs and client processes
Provided valued inputs for establishment, streamlining, and improvement of project processes
SME for team in preparation and reviewing of NIH/HA response documents
Performing RCA when required with the team and preparing CAPA
Senior Medical Writer Associate (Clinical Trial Disclosures) Kinapse May 2015 – Mar 2017
Pullareddy joined Kinapse as a Medical Writer Associate and promoted as Senior Medical Writer Associate within a span of 10 months.
Authoring and/or editing of pertinent regulatory documents such as:
a. Protocol registration form (PRF) and results registration form (RRF) to support clinical trial disclosure commitments
b. Clinical study documents or documents for regulatory submission such as patient lay summaries, clinical study report synopsis, etc.
c. External scientific communications i.e. abstracts, response documents, etc.
Disclosed more than 10 vaccine trials to clinicaltrials.gov and to EudraCT
Performing quality control checks of documents prepared by colleagues against pre-specified check-list and follow up independently till final submission
Ensuring timely registration of Clinical trial Protocol disclosures and results disclosures on Clinicaltrials.gov, EudraCT, CTRI and other National registries, etc.
To prepare team for Audit ready with updated regulatory guidelines and process and to prepare audit response report
Project management activities (effort tracker, project tracker, status updates, process improvement, query resolution, and issue escalation)
Assist in mentoring and training of new joiners and team members depending upon project requirement (on FDAAA guidelines, NIH requirements and EudraCT guidelines for results posting)
Subject matter expert for the service line in redaction and clinical trial disclosing activities
Performing RCA when required with the team and preparing CAPA
Providing support for the publication of internal Newsletter
Research Analyst (Clinical Research Services) QPS LLC Mar 2014 – May 2015
Writing clinical/regulatory documents such as clinical trial protocols, clinical study reports, investigator brochures, informed consent forms, clinical overviews and complying with GCP and ICH-E3 Guidelines for FDA, TFDA, Canada, EU, TGA and Russian Federation etc…
To support in the drafting and editing of lectures, presentations, and posters
Design, preparation and review of Phase-I study protocols (Pivotal-BABE), PK/PD Study synopsis as well as End point study synopsis
Sample size estimation for pivotal BABE Studies
Providing Medical data, Protocols for Ethics Committee Approval
Giving support in the drafting and editing of lectures, presentations, and posters
Faced audits from USFDA (twice), DCGI (twice), MCC and Various International and national sponsors.
Medical Writer (Clinical) Sipra Labs May 2012 – Mar 2014
Pullareddy joined Sipra Labs as a Trainee CRA and promoted as Medical writer within the span of 6 months.
Writing clinical/regulatory documents such as clinical trial protocols and complying with GCP and ICH-E3 Guidelines for FDA, TFDA, Canada, EU, TGA and Russian Federation etc…
Design & Preparation of TMF, IB, ICF, CRF and Study Case Report Form
Preparation and issuing of all other study related documents to the respective departments
Master in Pharmacy (Pharmacology) from The Tamilnadu Dr.M.G.R Medical University, Chennai, T.N (2010- 2012)
Bachelor in Pharmacy from Acharya Nagarjuna University, Guntur, A.P (2006 – 2010)
Trained in Drug Development, ICH GCP, Regulatory requirements and protocol specifics at QPS
Completed 7 months training at Sipra Labs, Hyderabad, India in Clinical department (As part of
2nd M.Pharm curriculum)
Completed 1 month training at Dr.Reddy’s Laboratories, Hyderabad, India
Recognized by client/ sponsor twice for “Innovation, Creativity and Drive for Results” and was awarded with Performance Recognition award
Received Double-up award (2 times) and Continuous improvement reward
Awarded with “Rewards and Recognition” as one of the best trainers while in Kinapse
Faced both internal and sponsor audits with negligible findings or minor findings
Soft Skills and Strengths:
Ability to integrate, interpret, and communicate clinical data succinctly in accordance with global document quality standards
Building relationship with clients/vendors and discussing medical writing issues in person, via e-mail or telecon
Experience in handling of multiple projects independently with sophisticated planning and prioritization, and deadline oriented
Project management skills (invoicing, resource forecasting, handling clients)
Address for communication : M. Pullareddy,
H.No: 4, Vipula nilaya, Rechanahalli 1st cross, Bangalore-560077
Date of Birth : 16-10-1987
Known Languages : Telugu, English, Hindi & Tamil
Marital Status : Married
I hear by declare that the information provided here is best of my knowledge.
Date: 22-August-2018 Pullareddy. Medikonda