Medical Writer Ii
1 month ago
**Description**
**Medical Writer II**
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**JOB SUMMARY**:
Clinical Trial Disclosure plays a critically important role in executing projects for Syneos global clients. He/she works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical, and technical information.
**Skills**:
We are looking for 1-2-year experience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH).
Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of Clinical Trial Disclosure fundamentals is expected.
**JOB RESPONSIBILITIES**
**1. Authoring and Quality Assurance of Project Activities**:
- Executes project specific activities with high quality and in 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 with Client process
- Medical writer will be preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various clinical registries
2. Additional Activities
Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirements.
**Qualifications**
**What we’re looking for**
- Educational qualifications: A minimum of a scientific graduate degree in life sciences.
- 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
- Person should understand & comprehend protocol and clinical study report from disclosure perspective.
- Good understanding of clinical trial disclosure fundamental
- Core competencies for this role include 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
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