Mumbai Maharashtra Safety writer Jobs – 5 Open Jobs Today

Medical writer
Tata Consultancy Services —Mumbai, Maharashtra
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Safety Writer
Fortrea —Mumbai, Maharashtra
- Full-time
- Doctoral degree
- English
- Microsoft Office
5d
Senior Medical Content Writer – Medical Communications
Centrix Healthcare Limited —Andheri West, Mumbai, Maharashtra
- ₹8,00,000 - ₹12,00,000 a year
- Full-time
- Medicine
- Master's degree
- Bachelor's degree
- Paid time off
- Paid sick time
Quick apply
10d
Safety Medical Writer
Fidelity Health Services —Mumbai, Maharashtra
- Bachelor's degree
Senior Manager — Fundraising Team
Arpan —Mumbai, Maharashtra
- Online application
- CRM software
- Microsoft Excel
- Master's degree

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Medical writer
Tata Consultancy Services —Mumbai, Maharashtra
Keep abreast of project status, clinical operating plans and ongoing/new studies as well as. Information that is required for content/document preparation.
Safety Writer
Fortrea —Mumbai, Maharashtra
At least 3 years' experience in the pharmaceutical industry, or at least 2 years of it in medical writing. Perform quality review of the safety reports prepared…
5d

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Medical writer

Tata Consultancy Services -
Mumbai, Maharashtra

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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

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Medical writer

Safety Writer

Senior Medical Content Writer – Medical Communications

Safety Medical Writer

Senior Manager — Fundraising Team

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