Maharashtra Technical writer Jobs – 168 Open Jobs Today

Safety Writer
Fortrea —Mumbai, Maharashtra
- Full-time
- Doctoral degree
- English
- Microsoft Office
3d
Information Developer
Qualys —Pune, Maharashtra
- Full-time
- English
- Microsoft Office
- Mentoring
Delivery Lead Manager
Accenture —Mumbai, Maharashtra
- Full-time
- Bilingual
- Analysis skills
- Agile
Data Scientist II
Mastercard —Navi Mumbai, Maharashtra
- Full-time
- Computer Science
- Finance
- Master's degree
20h
SEO Specialist
Content-Whale Private Limited —Andheri, Mumbai, Maharashtra
- ₹40,000 - ₹60,000 a month
- Full-time
- Marketing
- Bachelor's degree
- In-person
- Health insurance
- Flexible schedule
Quick apply
6d
Graphic Designer
Markenzo Worldwide —Goregaon East, Mumbai, Maharashtra
- From ₹40,000 a month
- Full-time
- Bachelor's degree
Quick apply
Team Member – Service Assurance
Aditya Birla Group —Maharashtra
- Customer service
- Communication skills
- Health insurance
Content Writer
Thrivetribe Wellness —Pune, Maharashtra
- Communication skills
Quick apply
Senior Marketing Manager
DNY Hospitality —Thane District, Maharashtra
- Marketing
- Master's degree
- Bachelor's degree
Senior Video Editor
Valasys Media —Kalyani Nagar, Pune, Maharashtra
- Monday to Friday
- AI
- Communication skills
Team Member - Social Media
Aditya Birla Group —Maharashtra
- Customer service
- Communication skills
- Health insurance
Sales Engineer
LRN Corporation —Mumbai, Maharashtra
- Full-time
- Hybrid work
- Sales
- B.Sc
- Analysis skills
- Health insurance
- Paid time off
Quick apply
Social Media Expert
Sunshine Manpower Solution And Services —Pune, Maharashtra
- ₹3,00,000 - ₹3,75,000 a year
- Social media management
- Master's degree
Content Writer cum Digital Marketing Executive
InfoBridge —Pune, Maharashtra
- English
- Bachelor's degree
Business Development Executive Job in Pune - Digital Marketing Tech Services
Dimakh Consultants —Pune, Maharashtra
- CRM software
- Computer Science
- Sales
Senior Motion Graphics & Video Specialist
Ecolab Inc. —Pune, Maharashtra
- Full-time
- Bachelor's degree
- AI
- Communication skills
AI Content Strategist
Comprint Tech Solutions —Mumbai, Maharashtra
- Part-time
- Doctoral degree
- AI
2d
Graphic Designer & Video Editor
Story Molders —Borivali, Mumbai, Maharashtra
- ₹30,000 - ₹55,000 a month
- Full-time
- In-person
- Communication skills
Quick apply
Graphic Designer
Break The Code —Andheri East, Mumbai, Maharashtra
- Urgently hiring
Graphic Designer
SM Group —Borivali, Mumbai, Maharashtra
- ₹7,500 - ₹25,000 a month
- Full-time
- In-person
- Communication skills
Quick apply

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Safety Writer

Fortrea -
Mumbai, Maharashtra

Apply Now

Job details

Full-time
3 days ago

Qualifications

Clinical research
Doctoral degree
English
Microsoft Office
Master's degree
Communication skills
Time management

Full job description

Job Overview:

Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. Perform report management activities and lead client communication for the assigned reports. Assist other medical writers in their safety deliverables, act as a co-author for complex or large reports. Provide oversight and quality review of reports prepared by peers or junior associates. Conduct scientific literature searches and review for safety reports or routine surveillance activities. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Summary of Responsibilities:

Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution.
Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Risk Management Plans, and other documents. Take ownership of the assigned deliverables and collaborate with internal/ client stakeholders and the client to get the required inputs.
Perform quality review of the safety reports prepared by junior or associate medical writers.
Author or contribute to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates.
Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
Prepare medical information responses for HCPs.
Author/contribute to signal reports (ad hoc and periodic) and safety issue analysis reports
Write subject narratives for adverse drug reactions and serious adverse events.
Internal and external (client) communication and co-ordination to get the required inputs.
Participate in creating and updating labels, e.g., Core Data Sheets, USPI, centralized SPCs, Med Guides.
Conduct literature searches for authoring several types of reports or routine surveillance activities. Review and propose updates needed if any to the search strategies. Review the articles selected by other medical writers/junior writers. Author literature abstracts/summaries and propose Company comments.
Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.
Ensure compliance of operations with governing regulatory requirements.
Create, maintain, and assume accountability for a culture of high customer service.
Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training.
And all other duties as needed or assigned.

Qualifications (Minimum Required):

Minimum of first degree in life sciences (or equivalent).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
At least 3 years' experience in the pharmaceutical industry, or at least 2 years of it in medical writing.

Experience (Minimum Required):

Excellent command of written and spoken English.
Good written and verbal communication skills.
Knowledge of MS Office.
Good organizational and time management ability.
Excellent interpersonal skills.
Scientific or Clinical research experience desirable.
Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH[1]GCP guidelines.

Preferred Qualifications Include:

Advanced degree (e.g., PhD or Masters) preferred.

Physical Demands/Work Environment:

Available for travel 5% of the time, including overnight stays as necessary consistent with project needs and office location.

Learn more about our EEO & Accommodations request here .

Apply Now

Refine Your Search

technical writer jobs in maharashtra

Safety Writer

Information Developer

Delivery Lead Manager

Data Scientist II

SEO Specialist

Graphic Designer

Team Member – Service Assurance

Content Writer

Senior Marketing Manager

Senior Video Editor

Team Member - Social Media

Sales Engineer

Social Media Expert

Content Writer cum Digital Marketing Executive

Business Development Executive Job in Pune - Digital Marketing Tech Services

Senior Motion Graphics & Video Specialist

AI Content Strategist

Graphic Designer & Video Editor

Graphic Designer

Graphic Designer

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