Senior Medical Writer (Redaction)
Syneos HealthSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
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 Responsibilities
We are looking for 4-8 years’ 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). 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.
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
2. Additional Activities
Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s)
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.