mumbai maharashtra tata projects Jobs – 119 Open Jobs Today

Medical writer
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Manager - Strategy & Special Projects - MDs Office - Mumbai - Lower Parel - JM
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SAP BTP
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Tata Consultancy Services —Mumbai, Maharashtra
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Tata Consultancy Services —Mumbai, Maharashtra
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DERM
Tata Consultancy Services —Mumbai, Maharashtra
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Scientific Writer
Tata Consultancy Services —Mumbai, Maharashtra
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Medical writer

Tata Consultancy Services -
Mumbai, Maharashtra

Apply Now

Job details

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Clinical research
Computer literacy
B.Sc
Writing skills
B.Pharma
Master's degree
Analysis skills
Science
Presentation skills
Bachelor's degree
M.Pharma
Pharmacy
Computer skills
Communication skills
Adobe Acrobat
Editing
Time management

Full job description

TCS is Hiring Medical Writer professionals

Experience – 3 to 6 years

Location: Mumbai, Pune

Job Description

Overall 3 years’ of authoring/editing experience in medical writing domain across

different therapeutic areas in clinical documents including clinical study protocol,

pediatric investigational plan, informed consent document, clinical study report,

investigator’s brochure, clinical summary of pharmacology, clinical overview (efficacy

and safety), briefing package/pre-meeting package preferred

Experience in preparation of clinical documents necessary for national and international

regulatory submissions to the US, European and other regulatory agencies

Clear, concise and scientific style of writing, with attention to detail

Strong analytical skills and expertise in writing and review of scientific/clinical

documents

Good knowledge of clinical research domain, ICH GCP principles, Common

Technical Document (CTD) structure and regulatory requirements

Effective coordination and presentation skills - good organization and time management skills

Exceptional interpersonal, verbal and written communication skills

Computer Literate: Knowledge of MS Word, PowerPoint, Adobe Acrobat, MS Excel, etc.

Reporting to (Role): Team Lead/Group Lead

Responsibilities

Setting, discussing and meeting expectations of the document during kick off and

subsequent meetings

Lead the authoring/editing of clinical documents, as mentioned above.

Ensure adherence to established processes, timelines, regulatory guidelines and applicable

standards, styles, guidelines

Perform quality review of the clinical documents within established timelines with

adherence to applicable guidelines, templates, and processes

Ability to effectively and proactively communicate with internal and external stakeholders,

including authors and key opinion leaders as appropriate (including problem-solving and

resolution of issues)

Keep abreast of project status, clinical operating plans and ongoing/new studies as well as

scientific literature within assigned project

Maintain and develop current knowledge of regulatory guidelines, technological advances

and industry standards

Training and mentoring of the new recruits/existing medical writers

Oversee live projects assigned to the new medical writers and guide them as required

As required, take on functional role and responsibilities of the role of

Documentation Lead –

o Lead PDRD deliverables for project and act as first point of contact for any

information that is required for content/document preparation

o Ensure alignment and content re-use across documents for a product

o Onboard lead document writers on document content alignment and timelines.

o Provide required source documents incl. information pert aining to study

documentation, relevant project contacts (authors, reviewers), developmental

strategy

o Actively participate in Regulatory Affairs Functional or other cross functional team

meetings

o Review content of document prior to finalization to ensure high quality prior to

initiation of author review or Expert Team Revie

Location

Mumbai

Job Function

BUSINESS PROCESS SERVICES

Role

Executive

Job Id

408771

Desired Skills

Medical Writing

Desired Candidate Profile

Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), M.SC., MASTER OF PHARMACY

Apply Now

Refine Your Search

tata projects jobs in mumbai maharashtra

Medical writer

Manager Governance

Manager - Strategy & Special Projects - MDs Office - Mumbai - Lower Parel - MM

Medical Reviewer

Manager-CSFD-Legal-Mumbai - Lodha (I-Think Techno Campus)-M1-M3

Manager - Strategy & Special Projects - MDs Office - Mumbai - Lower Parel - JM

F&A Transformation Lead

Analyst - Core Infra & Services Development

Head - Product - Micro Finance - Mumbai - Lower Parel - MM

Manager - Information Technology - Mumbai - Lodha (I-Think Techno Campus)

SAP BTP

Associate Manager - Scientific Writer

Business Analyst

SAP ABAP

Senior Program Manager

Recruiter

CEM Collections Lead

Deputy General Manager - Corporate Legal

DERM

Scientific Writer

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