Description

Principal Medical Writer (CTT)

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 all 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, 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.

Job Responsibilities

• 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, ,National registries (DIMDI))
• CTT Data base experience (Disclose, Prime, PRS, EudraCT)
• 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
• Additional Activities
  
  

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

Qualifications

What we’re looking for

We are looking for 8 years’ experience medical writer who will be involved in CTT/redactions/anonymization of clinical documents as part of 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, perform quality review, client communication and management.

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.

Qualification Requirements

• 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
• Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
• 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
  
  

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 discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.