sr Medical writer

Professional Profile of Dr. Rashmi Sharma (approx. 8 years corporate

experience)

Contact: **************@*****.***

077********

I am a dynamic, self-motivated, result-driven individual with a successful

background in medical writing, pharmacovigilance & clinical research. A

solution-oriented multi-tasker, experienced and versatile medical writer,

committed to achieve & exceed the set expectations in the demanding

projects, processes & meeting the business objectives.

1. Medical Writing:

2 Roche (Senior Regulatory Documentation Scientist)

3 Cognizant (Associate-Medical writing [Team Lead] -AstraZeneca, Novartis,

Allscripts)

4 Novartis (Scientific Writer II)

1. Roche (Contractor (03Jan2012-12Aug2013) and now permanent, since

12Aug2013- ongoing): Sr Regulatory-Medical writer (Applause

recognition - for teamwork and collaboration)

. Worked on following documents as a writer and/or reviewer and/or

coordinator and/or suite lead: Development Safety Update Report (DSUR),

Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation

Report (PBRER - New format EU PSUR), Risk Management Plan (RMP), addendum

to clinical overview (aCO), & Six Monthly SUSAR (SSR) reports

. Global Lead and Subject matter expert for aCO; Pandemic Safety Reports

(PSR) and Departmental initiative for comparative benefit risk (cBR)

. Mentoring: as a buddy to provide support to new joiners to facilitate the

onboarding -supporting the manager

. Write and/review and co-ordinate with stakeholders for Standard Operating

Procedures (SOP), Data Delivery Plan (DDP), work-in instructions (eg

Integrated working document) and writing projects

. Lead and/or support the departmental initiatives, team members, safety

and/or regulatory teams to prepare response documents to the

feedback/comments received from the Regulatory Agencies

. Ensure consistency and compliance within suite (DSUR, aCO, PSUR, PBRER

and/or RMP). Provide inputs and feedback for process and template

improvement. Project management; quality and time management of all the

assigned deliverables

. Coordinate across various stakeholders (in house, partners and outsourced

parties) and functions to ensure project and process requirements are met

. Review of the source documents - Business Object outputs, ARISg outputs,

biometric outputs and responsible for the consistency within the report

. Training: Ensure the training needs of assigned buddies are met. Maintain

and update training slides and provide training for stake-holders/cross

functional; vendors; and new-joinee.

. Miscellaneous: Support activities as & when required - Organized

regulatory files as per the company requirements; back-up/support for

team members; spot checking of documents; helping with schedules and

resource planning - verifying the pharmacovigilance agreements with

licensees/co development partners

2. Cognizant (11Jan2010- 19Aug2011): Associate-Medical writing (Team

Lead): SPOT recognition (by Novartis); WOW points (by Cognizant)

. Team Lead: Underwent numerous leadership, quality related and management

trainings (Selected and was trained as a Part of team trained for fast

track leadership)

. Project management activities: Writing & reviewing SOPs, working

instructions, RACI metrics, Process flows, Project planning, & tracking

. Client Management: Contributed to RFPs. Contributing in the preparation

of the site for Client visit, Interviews by the clients and on-site

work/support at Client's locations

. Training activities: Train The Trainer (TTT) certified trainer for CSRs,

PDE evaluator (internal reviewer), In-house mentor & Boot camp trainer

. Worked on following reports: ASRs (part of OJT and internal support),

CSRs (Phase II, III & III/IV), CTD narratives, 90 Day safety report, IB

updates, & Narratives (Novartis: FDA & MHRA submissions & for special ad-

hoc requests)

. Review of the source documents - protocol, statistical analysis plan,

TLFs, statistical report and responsible for the consistency

. Content writing (Allscripts): Preparing training courseware for

physicians

. Miscellaneous: Support activities as & when required - Review & update of

JDs, Individual Development Plans (IDPs), Team discussion sessions for

knowledge sessions & feedback sessions

3. Novartis (22May2008- 04Jan2010): Scientific Writer II (Above and

beyond award)

. Medical writer & reviewer for ASRs (Annual Safety Report), RMPs (Risk

Management Plan), CTD (Common Technical Document) summaries, CTRD

(Clinical Trials Results Database), Slide sets (for prestigious

conferences and internal presentations - training and data sharing), Flow

charts, SIPOC charts & CSR narrative-writing projects

. Data retrieval from various sources for narrative writing, ASR, CTRD &

CTD summaries

. Experience working with Clin Admin, I-Review, WDCS, ASR Assistant, CREDI

& I-Man etc.

. Writing & reviewing patient narratives for the clinical trials (14.3.3 &

PTS2 format)

. Project planning, Follow up & Track clinical trial milestones for RMP,

ASR & narrative writing

. Experience in creating SIPOC chart & Process Flow Diagrams for the

process

. Working as a Lead Writer, Co-Lead Writer, QC reviewer - Managing multiple

projects with cross cultural, versatile team

. Buddy-Mentor: Trained & helped new joinees to get on board and become

productive members of the team.

2. Pharmacovigilance (Approx. one year):

4. Satyam BPO (Pfizer) (26June2007- 09May2008): Sr HCPA (Pat on back

award)

. Worked in various roles - Lead, Mentor, QC reviewer, SME (subject matter

expert) & senior HCPA (healthcare professional assessor for litigation

cases)

. Job required medical knowledge, computer skills, good written skills,

knowledge of ICH-GCP & CFR 21 part 11, good knowledge of project specific

SOPs, Consistency Guides & guidelines, coding with the use of MedDRA &

WHO dictionaries

. Case assessment - source document review, data consistency, data entry;

case assessment; custodial review; selection, ranking & labeling of

events; selection & ranking of suspect drugs; selection of reporting

priorities; custodial proofing; reporting & forwarding in global safety &

tracking databases

. Writing clear, simple, chronological & concise narratives for the cases &

case dialogues; Editing previously entered data & completing the follow-

up case assessment, validation check of data bases & assigning

appropriate action to discrepancies

. Consistency check in safety & tracking data bases; time tracking,

addressing queries & issues/discrepancies with applicable solutions as

per guidelines

. Performed project tasks within project timelines with expected quality

standards (minimum quality requirement of 99.7%)

. Was involved in process specific SOP writing & reviewing - case

assessment, QC & QA

3. Clinical Research (Approx. one year):

5. L. V. Prasad Eye Institute (Pfizer, ScyFix)

Pfizer (01Sep2006 - 23Jun2007): Phase II/III multi-centric trial to

provide efficacy & safety data

. Submission of Study related documents to Ethics Committee & other study

related correspondence

. Selecting & getting team trained & certified as per protocol requirements

. Enrollment of patients, initial screening, randomization, & drug kit

allocation by using IDDI & RAVE Databases. All follow-up activities after

enrollment

. Certified PRO (Patient Reported Outcomes) Interviewer responsible for all

protocol related administration of PRO Questionnaires (VFQ-25 & ED 50)

. AE & SAE Monitoring & Reporting as per sponsor specifications

. Responsible for sending biological shipments to Central laboratory &

Reading Center as per regulations & study sponsor's SOP & guidelines

. Maintaining Trial Master File, Source Documents, documentation of

important correspondence

ScyFix (Nov2006- 23Jun2007): Pilot study (device) to provide initial

safety & efficacy data

. Writing, reviewing & correcting study documents- Clinical Trial

agreement, Site Budget, Protocol & Informed Consent Document

. Initial Budget calculations & Budget negotiation with Sponsor

. Ethics Committee Submissions, correspondence, assisting in answering

queries raised by ethics committee or scientific committee & follow-up

. Screening potential study subjects from existing patient pool,

administering ICF, training in device usage, telephonic assessment &

follow-up of the subjects

. Device-data collection & data processing, Adverse Event & SAE Monitoring

& Reporting

. Maintaining Trial Master File, Source Documents, documentation &

correspondence with sponsor

4. Internship (One Year):

Medicine, Surgery, Gynecology & Obstetrics, Ophthalmology, Ear, Nose and

Throat (ENT), Dermatology, Preventive and Social Medicine (PSM),

Pediatrics, & Homeopathic Medicine.

Education and Training:

. Post Graduate Diploma in Clinical Research: Institute of Clinical

Research (India) -ICRI, Bangalore

. Bachelor of Homoeopathic Medicine & Surgery: VYCH Medical College,

Kolhapur

. Cognizant: Leadership (Focus, Star certification & other leadership

trainings), Decision making, Effective communication, Communication at

workplace, Six Sigma, Lean methodologies, Statistics

. Novartis: GCP, Lab course, Role of Regulatory affairs in drug

development, Cross Culture Training, GCP & pharmacovigilane (4 day work-

shop by DIA), Six sigma yellow belt holder, LEAN workshop; Barry Drees

workshop

. Satyam bpo: Business writing, Cross cultural sensitization, English

grammar, narrative writing & FISH-creating energy at work place

. Project specific: RAVE, IDDI & Simplified trials applications, ARISg,

RSGT, ARGUS & eAEM data bases, Use of MedDRA, WHO dictionaries, case

assessment

. Other: Homeopathy Conference by George Vithoulcas, All India Homoeopathy

Conference, Organized & participated in GCP workshop at LVPEI, conceptual

knowledge of SAS, computer applications, MS Office suite of products,

Lotus Notes, Outlook Express & Internet

. Received academic and non academic merit certificates, state level

scholarships

Clinical Trial Capabilities:

. Good knowledge of drug development process, Informed Consent Process,

Site initiation, Monitoring, Study Close out, Trial Designs, Schedule Y,

Indian GCP, ICMR Guidelines, ICH-Guidelines & aware of US, UK & Canadian

regulations governing clinical trials, Pharmacovigilance

. Guest lectures at clinical research training institute - Monitoring in

Clinical research, Schedule Y, Inspection & Audits, Clinical Trial

Responsibilities

Contact this candidate