ClinChoice Medical Writer Opening – BSc Life Science Apply Online
ClinChoice Medical Writer Opening – BSc Life Science Apply Online. ClinChoice Senior Medical Writer Opening. The latest BSc Lifescience Job details are given below. Please apply now if your qualifications match the Latest BSc Lifescience Job.
Post – Senior Medical Writer
Location – Bengaluru, Karnataka, India
Primary Responsibilities:
The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, 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 clinical documents associated with submissions to regulatory authorities.
- Serve as QCer to review peer`s clinical documents.
- 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.
- 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.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- 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.
Qualifications –
- Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.
- Fluent in written and spoken English.
- Experience in the pharmaceutical industry or medical writing.
- Experience of 3-8 years of medical writing of regulatory documents such as CSR, protocol or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.
- 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.
Hello friends, we are attaching the expected interview questions and answers here. Once you apply for the Latest BSc Lifescience Job, please go through it and practice. All the best !!!
Question 1: Can you describe your experience in creating and editing clinical and regulatory submission documents? Answer: Certainly. Throughout my career, I have gained substantial experience in producing clinical study reports, protocols, safety update reports, and other regulatory submission documents. I have successfully worked on projects that required adherence to stringent guidelines and standards set by regulatory authorities. My experience spans over [X years], during which I have refined my skills in crafting well-structured and compliant documents that contribute to the successful submission process.
Question 2: How do you ensure that your written documents adhere to appropriate regulatory guidelines and comply with departmental and corporate SOPs? Answer: Ensuring document compliance is a critical aspect of my work. I meticulously review and cross-reference the guidelines provided by regulatory authorities, along with the specific SOPs outlined by our department and organization. I am well-versed in the latest industry standards and am committed to maintaining consistency and accuracy in each document I create. Regularly staying updated through workshops and conferences aids me in incorporating the most current regulatory requirements into my writing.
Question 3: Could you provide an example of a challenging project you’ve worked on, and how you managed to coordinate the production and distribution of draft and final documents for that project? Answer: Certainly. In a recent project, our team was tasked with preparing a comprehensive clinical study report within a tight timeline for a critical regulatory submission. I immediately established clear communication channels within the project team and client, ensuring everyone understood their roles and responsibilities. I developed a detailed timeline, accounting for document creation, review cycles, and formatting. Regular check-ins and feedback loops were established to ensure alignment throughout the process. By staying organized and working closely with team members, we were able to produce a high-quality document on time, meeting both internal and regulatory standards.
Question 4: How do you approach quality control and editing of documents prepared by other writers? Answer: When reviewing documents, I approach it with a dual focus on content and style. I perform a thorough review for accuracy, coherence, and completeness of the information presented. Additionally, I ensure that the document aligns with our established style guidelines and meets the necessary regulatory requirements. My goal is not only to catch errors but also to enhance the overall clarity and impact of the content. Constructive feedback is provided to writers, fostering a collaborative environment that facilitates continuous improvement.
Question 5: Could you discuss your familiarity with eCTD and its relevance in the medical writing field? Answer: Certainly. The electronic Common Technical Document (eCTD) is an essential format for regulatory submissions, streamlining the submission process and facilitating efficient review by regulatory agencies. I am well-acquainted with eCTD principles and practices, having utilized this format in various projects. My experience includes structuring documents according to eCTD specifications, ensuring that the content is appropriately tagged and organized for easy navigation. This familiarity with eCTD enhances the overall efficiency and accuracy of the submission process.
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