senior scientist or senior associate, RegulatorySyneos Health

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.
Senior Scientist, Regulatory
Role Purpose
Reporting to Regulatory Manager or above, a Senior Regulatory Scientist executes regulatory operational services for global clients. The role will work as part of high-performing team, of typically 3-8 people, on moderate-complex assignments involving the processing of regulatory information and project work.
Regulatory activities will be undertaken according to defined processes and operating procedures, which will be subject to internal and external audit.
Key Duties and Responsibilities * Project Delivery
Manages project deliverables in line with project plan
Proactively identifies moderately complex issues and risks to project delivery in own work or work of the team and escalates appropriately with associated resolution proposals
Undertakes project specific activities independently and within cost and time estimates
Responsible for process implementation and ensure process compliance
May act as Team Lead for functional disciplines.
May support the Manager or Senior Manager in delivery and/or the successful initiation, execution and completion of Regulatory, CMC or Publishing programs for Kinapse' Global clients
May be responsible for reviewing submission output from team members.
May assist in work allocation, compilation, tracking and reporting of the project reports on timely basis
May be responsible for creating or updating the SOPs, job aids as per project specific requirements
Participate in meetings with Client on a regular basis to understand the client's requirement for a particular project and proactively support the team in meeting or exceeding the targets in terms of quality, quantity within the scope of time constraints
Applies negotiation skills to recommend time lines and change in requirements
Act as a subject matter expert and help the team members with day-to-day trouble shooting activities
Problem Solving and Analysis
Exhibits a growing awareness of project strategy and thinking capability alongside independence
Reviews and provides solutions for issues relating to project delivery or escalates appropriately to the Team Leader/Program Leader/Program Director as required
May support identification and provides standards for gathering information for use in trend analysis
Client Relationship Management and Business Development
May proactively identify business development opportunities and internal business development efforts.
Seeks opportunities to increase internal client satisfaction and deepen client relationships
People Development
Have an awareness of those discussions which are sensitive and demonstrate these skills as necessary when the situation may arise.
May be a PDG lead with support from a more senior PDG lead
May be involved in people development in partnership with PDG leads
Provide training and mentoring of team members depending upon the project requirement
Training compliance
Ensure that all training (internal training and client training) are successfully completed in a timely manner
Qualifications
Competencies and Experience * Experience: 5-10 years
Bachelor's of Science Degree
Educational qualifications - Publishers:
A minimum of a graduate degree from a well-known institution
Experience in Regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical company are preferred
Significant knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred
Key skill requirement
Good oral / written communication skills
Working knowledge of basic office applications, e.g. MS Word/ PowerPoint/ Excel, will be required
Good analytical capabilities
Good presentation skills
Ability to lead / mentor junior team members
Enthusiasm, pro-activity and commitment to professional service
Ability to provide effective customer and stakeholder communications
Have a strong commitment to highest quality outputs
Effective team collaborator
Ability to be successful working in teams
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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
Syneos Health

Pasig City, Metro Manila
Permanent
Full-time