Syneos 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
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- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
- Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.
- Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.
- Attends client meetings as needed and builds client relationship in support of projects and deliverables.
- Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
- Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.
- Assists in training and mentoring of team members depending upon project requirements.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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.
http://www.syneoshealth.com
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.
Skills Required
- Experience preparing and submitting IND, marketing and lifecycle maintenance applications (CMC)
- Knowledge of regulatory requirements for EU, APAC and Gulf countries
- Experience performing document Quality Control (QC) reviews and tracking submissions
- Ability to undertake information processing activities reliably and meet tight timelines
- Experience maintaining regulatory records, logs, and regulatory databases
- Ability to work independently on non-complex submissions and under supervision for complex submissions
- Client-facing skills: attend client meetings and build client relationships
- Experience mentoring or training junior regulatory staff and maintaining training records
- Project awareness: identify risks to project delivery and propose resolutions for non-complex issues
Syneos Health Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Syneos Health and has not been reviewed or approved by Syneos Health.
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Leave & Time Off Breadth — Unlimited PTO for managers and flexible time‑off options make time away accessible and support work‑life balance. Day‑to‑day usability can depend on team and workload, but the policy breadth is a clear strength.
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Retirement Support — A 401(k) with company match is frequently highlighted as a strong component of the package. Despite vesting details to confirm, the retirement offering adds meaningful long‑term value.
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Parental & Family Support — Partnership with Maven provides fertility, adoption support, parental‑leave guidance, and women’s health resources across multiple regions. This family‑building support enhances the overall total rewards appeal.
Syneos Health Insights
What We Do
Syneos 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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
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