Assoc Dir, Regulatory Policy & Impact Assessment

Description

Associate Director, Regulatory Policy & Impact Assessment

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 Summary

The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities to the regulatory strategy and operations.

The Associate Director, Regulatory Policy and Impact Assessment is a key role that will represent Syneos Health at industry associations and lead the regulatory impact assessment process internally.

The purpose of the Associate Director is to support multiple industry policy campaigns by building Syneos Health’s policy position, assessing and engaging in external stakeholder groups, and representing Syneos Health on relevant external work groups affecting policy change. **

Job Responsibilities**

Lead Syneos Health Regulatory Impact Assessment

• Lead, coordinate, and manage the end-to-end regulatory impact assessment process for Syneos Health.
• Review the scope of new regulatory requirements and assess their impact and relevance to the operations.
• Partner with the Departmental Leadership and the Business to create and deliver a robust global regulatory impact assessment plan to ensure compliance.
• Support the decision-making process of the entire organization regarding new country and regional regulations, its positive and negative effects on Syneos Health operational processes.
• Liaise with relevant internal stakeholders in respect of regulatory developments and provide advice as required.
• Work collaboratively with the cross functional teams to ensure that there is a common understanding of significant regulatory change matters.

Support Multiple Policy Campaigns

• Monitor the external environment for new regulations and possible implications to Syneos Health and communicate with internal stakeholders.
• Perform stakeholder analyses to understand external perspectives on key Syneos Health policy priorities.
• Track, monitor, and provide analysis of relevant regulations, as directed by Syneos Health management.
• Maintain a record of all relevant industry developments and impact on Syneos Health.
• Manage and oversee Syneos Health participation in industry meetings.
• Coordinate cross functional input to draft guidance documents.
• Represent Syneos Health by providing comments to draft guidance documents either through industry associations or directly to regulators.
• Participate as a member of trade association teams to leverage Syneos Health’s position.
• Interact and liaise closely with key regulatory health authorities.
• Create and contribute to thought leadership and communications (for both internal and external audiences).
• Act as an expert resource for internal stakeholders on new regulations.
• Develop relationships with key external stakeholders to understand their perspectives and inform them regarding Syneos Health’s position.

Contribute to the Regulatory Intelligence Data Maintenance

• Analyze Assoc Dir, regulatory information to provide summary outputs and create new regulatory intelligence data points.
• Report to management on key aspects of regulatory changes.
• Support the work of the Regulatory Intelligence department, including risk reporting, resource, and budget management.
• Perform other work-related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications

QUALIFICATION REQUIREMENTS

• BA/BSc in related disciplines or regional equivalent or equivalent combination of education and experience.
• Minimum 8 - 10 years of regulatory experience required.
• Prefer prior regulatory policy experience.
• Health authority experience preferred.
• Drive effective coordination and decision-making among cross-functional stakeholder groups.
• Ability to represent Syneos Health in industry or policy organizations.
• Strong interpersonal skills and demonstrated ability to manage external and/or internal relationships with key stakeholders.
• Ability to research and write briefings, positions, and high-level communications.
• Independence, resourcefulness, influence without authority.
• Demonstrable leadership skills.
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.
• Ability to think strategically, make effective decisions based on data and insights and manage multiple priorities while delivering high quality work in a dynamic environment.
• Fluency in speaking, writing, and reading English.
• Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills.
• Ability to establish effective relationships with a range of stakeholders, externally and internally.
• Excellent problem solving and decision-making skills.

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.

_“Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.”

_ 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.

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