Manager - CSR Writing

Found in: Talent IN C2 - 3 weeks ago

Hyderabad, India ClinChoice Full time

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

    Found in: Whatjobs IN C2 - 3 weeks ago

    hyderabad, India ClinChoice Full time

    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...

  • Esg Report Writing

    6 days ago

    Hyderabad, India Apex Group Full time

    ESG Report Writing Location: Hyderabad, India Date Posted: Jul 25, 2023 **Description** - Portfolio Monitoring and Reporting team - Alternative Investments, Private Equity**Employment Type (full time)**: ***Associate / Senior Associate / AVPThis is an excellent opportunity for a highly motivated professional to join our global PortfolioMonitoring team....

  • Technical Writing Manager

    Found in: Whatjobs IN C2 - 5 days ago

    hyderabad, India AVEVA Full time

    Position: 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

    Found in: Whatjobs IN C2 - 5 days ago

    Hyderabad, India AVEVA Full time

    Position: 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...

  • Technical Writing Manager

    Found in: Appcast Linkedin IN C2 - 6 days ago

    Hyderabad, India AVEVA Full time

    Position: 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

    Found in: Talent IN 2A C2 - 6 days ago

    Hyderabad, India AVEVA Full time

    Position: 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;...

  • Content Writing

    4 days ago

    Hyderabad, India Vinil It Services Full time

    Designation: Content Writer Skill set Experience: - An enthusiastic and ambitious team player with an eye for detail and commitment - Good organization, planning and teamwork skills. - Ability to multitask with problem-solving skills - Adaptability. A great content writer understands that different clients have different needs when it comes to things like...

  • Content Writing

    4 days ago

    Hyderabad, India Amazon Full time

    **JOB DESCRIPTION** Have you always wanted to be a part of something bigger? Something that charts a course to the future? Do you want to see the work you do make a change in the world of tomorrow? Do you thrive on solving problems, spotting patterns and working in an ever-changing environment? **KEY JOB RESPONSIBILITIES** - Work on various writing work...

  • Web Content Writing

    Found in: Talent IN C2 - 3 weeks ago

    Hyderabad, India VoIP Office Telecommunication Full time

    Organisation name : VOIP Office TelecommunicationRole : Content WriterWorking Timings : 2 PM TO 11 PM - Monday to Friday / 3 PM TO 10 PM on Saturdays Location: TRENDZ UTILITY, Plot No.25, Survey No.37- 41 3rd Floor, Vittal Rao Nagar Rd, Gafoornagar, Telangana 500081Roles and Responsibilities:1)Research and organize sources and information.2)Collaborate and...

  • Corporate Relations Manager

    Found in: Whatjobs IN C2 - 3 weeks ago

    hyderabad, India MS Agarwal Foundries Pvt Ltd Full time

    Minimum 5 -7 Years in Corporate relationsTo develop and maintain relationship with Government agencies and other stakeholders to ensure that the company is in compliance with regulationsPublic Relations: Develop and execute public relations strategies to enhance the company's image and reputation.Coordinate press releases, media events, and interviews to...

  • Corporate Relations Manager

    Found in: Whatjobs IN C2 - 3 weeks ago

    hyderabad, India MS Agarwal Foundries Pvt Ltd Full time

    Minimum 5 -7 Years in Corporate relations To develop and maintain relationship with Government agencies and other stakeholders to ensure that the company is in compliance with regulations Public Relations: Develop and execute public relations strategies to enhance the company's image and reputation. Coordinate press releases, media events, and interviews...

  • Corporate Relations Manager

    Found in: Whatjobs IN C2 - 3 weeks ago

    Hyderabad, India MS Agarwal Foundries Pvt Ltd Full time

    Minimum 5 -7 Years in Corporate relations To develop and maintain relationship with Government agencies and other stakeholders to ensure that the company is in compliance with regulations Public Relations: Develop and execute public relations strategies to enhance the company's image and reputation. Coordinate press releases, media events, and...

  • Corporate Relations Manager

    Found in: Appcast Linkedin IN C2 - 3 weeks ago

    Hyderabad, India MS Agarwal Foundries Pvt Ltd Full time

    Minimum 5 -7 Years in Corporate relationsTo develop and maintain relationship with Government agencies and other stakeholders to ensure that the company is in compliance with regulationsPublic Relations: Develop and execute public relations strategies to enhance the company's image and reputation. Coordinate press releases, media events, and interviews...

  • Corporate Relations Manager

    Found in: Talent IN 2A C2 - 3 weeks ago

    Hyderabad, India MS Agarwal Foundries Pvt Ltd Full time

    Minimum 5 -7 Years in Corporate relationsTo develop and maintain relationship with Government agencies and other stakeholders to ensure that the company is in compliance with regulationsPublic Relations: Develop and execute public relations strategies to enhance the company's image and reputation. Coordinate press releases, media events, and interviews...

  • R&D Manager, Technical Writing

    Found in: Talent IN C2 - 6 days ago

    Hyderabad, India AVEVA Full time

    AVEVA 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

    Found in: Whatjobs IN C2 - 4 days ago

    hyderabad, India AVEVA Full time

    AVEVA 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...

  • Regulatory Writer

    2 weeks ago

    Hyderabad, India Novartis Full time

    900! 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...

  • Transfer Agency

    1 day ago

    Hyderabad, India Apex Group Full time

    Transfer Agency - Associate Location: Hyderabad, India Date Posted: Mar 13, 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

    Found in: Talent IN C2 - 3 weeks ago

    Hyderabad, India Corteva Agriscience Full time

    Description 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...

  • Communications Manager, India

    Found in: Whatjobs IN C2 - 2 weeks ago

    hyderabad, India Corteva Agriscience Full time

    Description 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...