Regulatory Labelling Consultant (Serbia/UK/Spain)

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.

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.

Responsibilities:

• Attend labeling governance meetings and draft accurate minutes in a timely manner. Upload minutes to the electronic document management system.
• Proof-read and coordinate data QC labeling documents for grammar, spelling, punctuation, and formatting. Verify accuracy and consistency of the labeling contents.
• Ensure compliance to labeling process and timelines through reporting, metrics and data management in the label tracking system.
• Develop and manage labeling department templates.

Required Knowledge/Skills:

• Experience with taking meeting minutes and ability to distill messages in a concise and accurate manner.
• Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of documents. Familiarity with Veeva is desirable.
• A strong command of English language including grammar, spelling, and punctuation and exceptional proofreading and editing skills.
• Experience using Label tracking systems, e.g. Intagras, Veeva Labeling.
• Prior experience using proof reading tools, e.g. TVT, Global Vision desirable.
• Ability to communicate and work effectively with labeling stakeholders.

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.

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.