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Medical Writer I
3 weeks ago
**Description**
**Medical Writer (CTD) role**
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- 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**:
CTD 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 minimum of 6 months to 2 years’ experience in medical writing who will be preparing disclosure documents for clinicaltrials.gov and for various clinical registries. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of clinical trial disclosure fundamentals.
**JOB RESPONSIBILITIES**:
- Works cross-functionally and collaboratively to plan and coordinate the global transparency activities (authoring results registration form on clinicaltrials.gov and EudraCT, Clinical Data Sharing, and other transparency-related activities in the EU, US and third countries) and to ensure/support compliance with procedures and to manage external communication
- Ensuring development of high-quality deliverables that are compliant with all applicable policies, procedures, and regulations
- Undertakes project specific activities at high quality and in defined timelines according to standard processes and operating procedures
- Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP
- Maintain accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking
- Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs
- Ensure to abide with Client process
- Completion of Internal and Client specific training
**Qualifications**
**What we’re looking for**
- MPharm qualification with relevant writing experience with relevant scientific and/or medical knowledge and expertise.
- Must have experience in Medical writing/ Regulatory Writing/ CTD domain
- 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.
- Basic 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
- Enthusiasm and pro-activity
- Effective team working
- Ability to build rapport/ relationships with project-specific client colleague
**Get to know Syneos Health**
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
**Additional Information**:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discr
