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Regulatory Consultant - Regulatory Submissions Publisher / Manager at Parexel in Waltham, Massachusetts

Posted in Other 30+ days ago.

Type: Full Time





Job Description:

Are you an experienced Regulatory Publisher who is looking to combine your publishing expertise with your passion for delivering on time quality submissions? Who is looking for an opportunity work from home? Who has superior interpersonal skills and enjoys establishing and maintaining internal and external relationship? And also is looking for an opportunity work alongside some of the Industry s best? If you answered yes to these questions, Parexel Consulting's growing Team has an excellent opportunity for you!

We currently have an amazing opportunity to join Parexel s Regulatory Consulting Team as a Regulatory Publishing Consultant. A Regulatory Publishing Consultant must have strong technical publishing skills for regulatory knowledge and electronic submission skills in the eCTD format and may be developing specialist knowledge of a particular subject and/ or market. Additionally, a Regulatory Publishing Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, he/she assures the work of the entire team or work stream is delivered on time and that it meets client s and PC s quality expectations; functions as the main client contact and ensures accurate project reporting is in place; ensures that appropriate risk identification and issue-escalation procedures are in place; ensures project specific training compliance of the project team; ensures and/or manages project financials including provision of accurate revenue forecast; ensures that the project team understand and work to the scope of the contract; identifies new opportunities through Change In Scope or add-on business from existing work; and ensures timely project close-out activities are completed.QualificationsTo ensure success, you will have:

Minimum of a Bachelor s Degree in a Scientific or Technical Discipline is required, Advanced Degree Preferred
5+ years of regulatory publishing experience with strong eCTD experience
Previous experience with electronic publishing software (previous InSight Publisher experience is a plus, but not required)
Previous experience with US and Canadian Health Authority Submissions is required. European and ROW Heath Authority experience is a plus!
Demonstrated industry related project management experience and past experience overseeing a global team to achieve quality project deliverables within specified timelines
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language
The ability to travel domestically and internationally up to 30% may be requiredEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status..