Medical Clinical

PULLAREDDY. MEDIKONDA

Email: ***********@*****.*** Cell: +91-970*******

LinkedIn: in/pullareddy-medikonda-696b9434/

Summary:

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.

Expertise:

- 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...

Experience:

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.

Key Roles:

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.

Key Roles:

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

Key Roles:

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.

Key Roles:

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

Education:

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)

Industrial trainings:

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

Achievements:

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)

Personal Details:

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

Declaration:

I hear by declare that the information provided here is best of my knowledge.

Place: Bangalore,

Date: 22-August-2018 Pullareddy. Medikonda

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