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Not Disclosed by Recruiter Posted 30+ days ago Job Applicants: 49 Job Views: 236

Job Description

 
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    Serve as the Medical Writing representative on assigned project.

    Needs to work on more than 1 project at a time if required.

    Creative content development and writing high-quality , original scientific copy for any of a variety of target audiences (e.g. , pharmaceutical sales representatives , physicians , and patients).

    Perform literature searches / reviews as necessary to obtain background information and training for development of documents.

    Refined and detailed researching and referencing utilizing AMA style.

    Attend internal team and client team meetings as required.

    Ensure that all work is complete and of high quality prior to shipment to client.

    Provide training and guidance and act as a mentor to less experienced departmental members.

    To review timelines and ensure that Project Manager / Client are informed of current status. To recommend actions and implement actions if timelines is not on target.

    To assist in the review and QC process for documents within medical Writing.

    To ensure that work is in compliance with the relevant regulatory guidelines.

    To undertake other project related tasks , as assigned by the Line Manager.

    Set priorities for writing tasks and ensure deadlines are maintained.

    Provide input to Project Managers and Managers to ensure that project requirements for Medical Writing are adequately reflected in the objectives of the project team.

    Co-ordinate the development and communication of study start-up plans and project-specific procedures , guidelines , documents and forms , in line with relevant SOPs , ICH / GCP and local requirements.

    Closely monitor study progress within the scope of Medical Writing against plan , identify any significant variance and report to Project Manager.

    Ability to recognise out of scope costs and to raise with Project Manager as appropriate.

    Serve as a proactive member of the core project team , liaising closely with the Project Manager on all Medical Writing-related issues.

    Experience , Skills , Knowledge Requirements:

    Minimum 3 years experience in medical writing and review.

    Must possess the ability to manage large projects with minimal supervision.

    Must possess the ability to coordinate production of deliverables and provide leadership to a project team.

    Must possess independence in decision making and problem solving.

    Must demonstrate an ability to serve as a departmental resource for training , mentoring , and the development of process improvements for Medical Writing.

    Must possess all requisite skills of the Medical Writer position , including excellent grammatical , editorial , and proofreading skills , and the ability to interpret and present extremely complex data.

    Knowledge of clinical research processes and drug development.

    Able to quickly grasp and accurately interpret clinical data

    Good written and oral English language skills and scientific style of writing with a high level of attention to detail.

    Attention to scientific accuracy and stylistic detail.

    Ability to produce detailed , comprehensive documentation.

    Resourceful and detail-oriented with excellent follow-through skills.

    Excellent computer skills , including proficiency in Microsoft Office and Adobe Acrobat and graphic software (Sigma Plot).

    Effective time management , flexibility and ability to meet challenging deadlines without compromising high quality outputs.

    Understanding of the principles of ICH-GCP and regulatory requirements.

    Good knowledge of SOPs and accepted practices.

    Good interpersonal and communication skills when dealing with Sponsors , supporting colleagues and making presentations

Salary: Not Disclosed by Recruiter

Industry: Pharma / Biotech / Clinical Research

Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Documentation/Medical Writing

Employment Type: Permanent Job, Full Time

Keyskills

Desired Candidate Profile

    Please refer to the Job description above

Education-

UG: Any Graduate

PG:Post Graduation Not Required

Company Profile:

Jeevan Scientific Technology Limited

Jeevan Scientific Technology Limited, established in the year 1999, is a global management consulting, technology services and outsourcing company located in Hyderabad, India.

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