Manager - CSR Writing
1 month ago
Manager - CSR Writing
Full-Time
Bengaluru, Karnataka, India
Hyderabad, Telangana, India
Description
Primary Responsibilities:The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update reports, etc.
The Medical Writer may provide writing support for more complex clinical documentation, with appropriate departmental supervision. The Medical Writer may serve as primary technical contact with client under appropriate departmental supervision.
Key responsibilities and skills may include, but are not limited to:
• Serve as the primary client contact under departmental supervision.
• Serve as the Medical Writing representative on assigned project teams, providing support to Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
• Providing support to Business Development Department for project bidding, document review and forecasting timeline.
• Write /Review clinical documents associated with submissions to regulatory authorities.
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
• Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
• Coordinate production and distribution of draft and final documents to project team and client.
Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
• Attend internal technical team and client team meetings as required.
• Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.
• Participate in departmental or interdepartmental process improvement and training initiatives.
• Other assignment duties as assigned by department management.
Requirements
Qualification: Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.Years of Experience
Should have 10-13 years of experience in medical writing of regulatory documents such as CSR, protocol, CTD sections or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.Skills
• Experience in the pharmaceutical industry or medical writing. Specific experience in Oncology and Neurology Therapeutic areas. • Good clinical/scientific writing skills.• Excellent interpersonal, verbal, and written communication skills.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Good word processing skills/familiarity with Word for Windows.
• Experience with eCTD preferred.
-
Manager - CSR Writing
1 month ago
Hyderabad, India ClinChoice Full timeManager - CSR Writing Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Primary Responsibilities: The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update...
-
Medical Writer
4 weeks ago
Madhapur, Hyderabad, Telangana, India Makrocare Full time**Company Description**: **MakroCare** is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical,- Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New- Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,- Medical/Scientific Support and...
-
Technical Writing Manager
2 weeks ago
hyderabad, India AVEVA Full timePosition: Technical Writing ManagerPrevious experience: Design, develop, review, and publish high-quality technical documentationLocation: Hyderabad, India – Hybrid (~60% office, ~40% remote)Employment type: Full-time regular (flexible working options available)Benefits: Competitive salary; high quality healthcare for employee, dependents, and...
-
Technical Writing Manager
3 weeks ago
Hyderabad, India AVEVA Full timePosition: Technical Writing ManagerPrevious experience: Design, develop, review, and publish high-quality technical documentationLocation: Hyderabad, India – Hybrid (~60% office, ~40% remote)Employment type: Full-time regular (flexible working options available)Benefits: Competitive salary; high quality healthcare for employee, dependents, and parents;...
-
Technical Writing Manager
3 weeks ago
Hyderabad, India AVEVA Full timePosition: Technical Writing ManagerPrevious experience: Design, develop, review, and publish high-quality technical documentationLocation: Hyderabad, India – Hybrid (~60% office, ~40% remote)Employment type: Full-time regular (flexible working options available)Benefits: Competitive salary; high quality healthcare for employee, dependents, and parents;...
-
Technical Writing Manager
2 weeks ago
Hyderabad, India AVEVA Full timePosition: Technical Writing Manager Previous experience: Design, develop, review, and publish high-quality technical documentation Location: Hyderabad, India – Hybrid (~60% office, ~40% remote) Employment type: Full-time regular (flexible working options available) Benefits: Competitive salary; high quality healthcare for employee, dependents, and...
-
Cs Writing Scientist
4 weeks ago
Hyderabad, India Haleon Full time**Job Description**: **Site Name**: India - Andra Pradesh - Hyderabad **Posted Date**: Jan 25 2023 Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne,...
-
Content Writing Internship
5 days ago
Hyderabad, Telangana, India Next Education India Private Limited Full timeAbout the internship:Selected intern's day-to-day responsibilities include:1. Create engaging content for blogs, social media, and marketing materials2. Edit and proofread content for clarity and consistency3. Optimize content for SEO and track performance using analytics4. Collaborate with cross-functional teams and incorporate feedback5. Contribute to...
-
Fundraiser
4 weeks ago
Hyderabad, India Generous Hearts Foundation Full time**Lead - CSR/Fund Raising & Donor Relation** CSR - Lead (Fundraising & Donor Relations Manager) - Support the development of the fundraising strategy and execution plan across key donor stakeholder groups including - Corporate donors and Foundations. - Manage the fundraising life-cycle from identification, qualification, cultivation, solicitation and...
-
R&D Manager, Technical Writing
3 weeks ago
Hyderabad, India AVEVA Full timeAVEVA is a global leader in industrial software. Our cutting-edge solutions are used by thousands of enterprises to deliver the essentials of life – such as energy, infrastructure, chemicals and minerals – safely, efficiently and more sustainably. We’re the first software business in the world to have our sustainability targets validated by the...
-
R&D Manager, Technical Writing
2 weeks ago
hyderabad, India AVEVA Full timeAVEVA is a global leader in industrial software. Our cutting-edge solutions are used by thousands of enterprises to deliver the essentials of life – such as energy, infrastructure, chemicals and minerals – safely, efficiently and more sustainably. We’re the first software business in the world to have our sustainability targets validated by the...
-
▷ [Only 24h Left] Technical Writing Manager
3 hours ago
Hyderabad, India AVEVA Full timePosition: Technical Writing ManagerPrevious experience: Design, develop, review, and publish high-quality technical documentationLocation: Hyderabad, India – Hybrid (~60% office, ~40% remote)Employment type: Full-time regular (flexible working options available)Benefits: Competitive salary; high quality healthcare for employee, dependents, and parents;...
-
Regulatory Writer
1 month ago
Hyderabad, Telangana, India Novartis Full time900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...
-
Customer Service Associate
5 days ago
Hyderabad/ Secunderabad, India timesjobs Full timeJOB DETAILS1.Perform Point of Sale procedures2.Ensure demand and manage floor stock3.Visual Merchandising and display as per guidelines4.Deliver a high level of customer service5.Build customer confidence of customers by making the store experience interactive, engaging and reassuring6.Adhere to the standard operating procedure and the policies of the...
-
Customer Service Associate
5 days ago
Hyderabad/ Secunderabad, India timesjobs Full timeJOB DETAILSPerform Point of Sale proceduresEnsure demand and manage floor stockVisual Merchandising and display as per guidelinesDeliver a high level of customer serviceBuild customer confidence of customers by making the store experience interactive, engaging and reassuringAdhere to the standard operating procedure and the policies of the...
-
Expert Regulatory Writer
4 weeks ago
Hyderabad, Telangana, India Novartis Full time392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...
-
Associate -transfer Agency
1 month ago
Hyderabad, India Apex Group Full timeAssociate -Transfer agency Location: Hyderabad, India Date Posted: Feb 17, 2023 **Description** - Transfer Agency Trade Processing TeamBusiness - DealingRole Title - Associate/ Senior Associate/ AVPLocation Pune/ BangaloreThe Transfer Agency Department provides Fund Administration service to numerousfunctions including Transaction processing, Reporting,...
-
Transfer Agency
1 month ago
Hyderabad, India Apex Group Full timeTransfer Agency - Associate Location: Hyderabad, India Date Posted: Feb 17, 2023 **Description** - Transfer Agency Trade Processing TeamBusiness - DealingRole Title - Associate/ Senior Associate/ AVPLocation Pune/ BangaloreThe Transfer Agency Department provides Fund Administration service to numerousfunctions including Transaction processing, Reporting,...
-
Transfer Agency
4 weeks ago
Hyderabad, India Apex Group Full timeTransfer Agency - Associate Location: Hyderabad, India Date Posted: Feb 22, 2023 **Description** - Transfer Agency Trade Processing TeamBusiness - DealingRole Title - Associate/ Senior Associate/ AVPLocation Pune/ BangaloreThe Transfer Agency Department provides Fund Administration service to numerousfunctions including Transaction processing, Reporting,...
-
Communications Manager, India
4 weeks ago
Hyderabad, India Corteva Agriscience Full timeDescription Communications Manager, India At Corteva we grow what matters by playing a critical role in feeding the world and enabling farmers to produce crops in ways that are sustainable for their families, their land, and the broader environment. We strive to bring our best selves to work every day: inspiring each other, acting boldly, and...