Syneos Health Medical Writer Opening – MSc Life Science Candidates Apply Online

Syneos Health Medical Writer Opening – MSc Life Science Candidates Apply Online

Syneos Health Medical Writer Opening – MSc Life Science Candidates Apply Online. Syneos Health is the leading fully integrated biopharmaceutical solutions organization organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. The details of the MSc Medical Writer Job are provided below. You can go through the details and apply online.

Role – Medical Writer II (Clinical Trial Transparency /Redaction)

Location –

Job ID- 23004969

Job Summary:

We are looking for a medical writer who will be involved in the redactions/anonymization of clinical documents as part of the preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, and perform quality reviews, client communication, and management.

Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from a disclosure perspective. Good understanding of clinical trial disclosure fundamentals.

Job Responsibilities – 

1. Authoring and Quality Assurance of Project Activities

• Executes project-specific activities with high quality and within defined timelines according to standard processes and operating procedures
• Marking /QC/Review and/or editing of pertinent documents such as:
• Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH)
• Protocol and results summaries to support clinical trial disclosure commitments
• Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP
• Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs
• Ensure to abide by Client process

2. Additional Activities

• Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s)

Qualifications:

REQUIRED SKILLS:

• A minimum of a scientific post-graduate degree in life sciences.
• Require 2 years of experience in Medical Writing for MW-ll and Minimum 5 years of experience in Medical Writing for Sr Medical Writer
• Must have experience in results & protocol Summary experience with exp in Results & Protocol summary experience (ideal)
• Require clinical trial registry experience – CT.GOV or EUDRACT even if they don’t have results or protocol-relevant experience. Market research candidates in these clinical registries are also fine.
• Good knowledge of regulatory requirements or guidance pertinent to the service line.
• Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills
• Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
• The person should understand & comprehend protocol and clinical study report from a disclosure perspective.
• Good understanding of clinical trial disclosure fundamental Core competencies for this role include the ability to demonstrate:
• Analytical capabilities with scientific and clinical data
• Professional working environment
• Ownership of the work allocated
• Commitment to highest quality outputs, including high attention to detail
• Enthusiasm and pro-activity
• Effective team working
• Ability to build rapport/ relationships with project-specific client colleague

APPLY ONLINE

Greetings! We have compiled the anticipated interview questions and their corresponding answers for the MSc Medical Writer Job. Take some time to review them thoroughly and prepare them effectively. Best of luck with your interview preparation!

Question 1: Can you describe your experience with clinical trial documentation and the different regulations mentioned in the job description? Answer: Certainly. I have over [X] years of experience in medical writing, specifically [Y] years as a Senior Medical Writer. During this time, I have been extensively involved in preparing and redacting clinical documents for various regulations such as EMA policy 0070, Health Canada PRCI, EUCTR regulation, and the final rule-NIH. I am well-versed in these regulations and have a deep understanding of the requirements they entail. My experience includes authoring and reviewing clinical study reports, patient narratives, clinical summaries, as well as protocol and results summaries for clinical trial disclosure. I am confident in my ability to perform quality reviews and ensure compliance with these regulations.

Question 2: Could you provide an example of a challenging situation you’ve encountered while redacting clinical documents for regulatory submission, and how you successfully resolved it? Answer: Certainly. In a recent project, I encountered a situation where the regulatory guidelines for EMA policy 0070 and NIH’s final rule appeared to conflict in terms of the level of detail required for clinical summaries. To resolve this, I carefully reviewed both sets of guidelines and conducted internal discussions with the team. I collaborated with regulatory experts to clarify the expectations, ensuring that we met the requirements of both regulations. This experience highlighted the importance of clear communication, collaboration, and thorough understanding of regulatory nuances.

Question 3: Can you discuss your experience with clinical trial registry disclosures, specifically with platforms like clinicaltrials.gov and EUDRACT? Answer: Certainly. I have hands-on experience with clinical trial registry disclosures, including platforms like clinicaltrials.gov and EUDRACT. I’ve successfully prepared and submitted Protocol Registration Forms and Result Registration Forms to these registries, ensuring accurate and compliant documentation. While my primary expertise lies in results and protocol summaries, I’ve also worked with colleagues to ensure complete and accurate registry submissions, aligning with the relevant regulations and guidelines.

Question 4: How do you ensure quality control in your medical writing projects, especially when reviewing documents prepared by colleagues? Answer: Quality control is a vital aspect of medical writing, and I take it seriously. When reviewing documents prepared by colleagues, I follow a systematic approach. I refer to pre-specified checklists generated for the project or SOP to ensure that each document aligns with regulatory requirements and internal standards. Additionally, I conduct detailed analyses on both a planned and ad hoc basis to identify any potential discrepancies or inaccuracies. Clear communication with my colleagues is crucial, as it helps address any issues promptly and collaboratively, thereby maintaining the highest quality outputs.

Question 5: Can you elaborate on your experience with mentoring and training team members in medical writing projects? Answer: Certainly. I have had the opportunity to contribute to the development of my team members’ skills through mentoring and training. Depending on project requirements, I’ve assisted in providing internal and client-specific training to help team members understand the regulatory landscape, document preparation processes, and quality control practices. This mentoring approach not only improves the team’s overall proficiency but also fosters a collaborative and knowledge-sharing environment, contributing to the success of the projects we undertake.

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