Regulatory Affairs Consultant (Clinical Regulatory Writing) 6/6/2020
JOB DESCRIPTIONAPPLY Are you an experienced Medical Writer who is looking to develop more technical writing skills and regulatory strategy exposure? If so, we currently have amazing opportunities to join Parexel's Consulting team as Clinical Regulatory Affairs Consultants and work alongside an incredibly talented client team!
As a dedicated partner to the client you will:
Support Product Development RA Program Manager in his/ her responsibilities and assist the Product Development RA Program Manager to accomplish his/her tasks in meeting deadlines to achieve the projects, teams and departmental goals
Prepare regulatory submissions in collaboration with the other disciplines in Product Development Research
- Support IND/NDA/BLA maintenance, support filings (INDs, BLAs, NDAs), support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and coordinate answers to regulatory questions.
-Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Affairs-specific systems, processes,
- Establishes effective working relationships internally and externally with regulatory authorities.
- Documents meetings, teleconferences and other interactions/communications with regulatory authorities.
- Additional regulatory- and project-related support activities/services as requested by the client project lead(s)/team(s).
- Ensures compliance with SOPs and national regulations.
Participates in and/or otherwise supports development and implementation of new or updated Product Development Research and/or Regulatory Affairs-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools as appropriate
Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
Participates in other special projects, as and when assigned, or otherwise requested
Remain, at all times, fully abreast and apprised of evolving internal and external needs, processes and requirements as appropriate. Expected to share best practices within the department and cross functionally, identify and communicate opportunities for departmental enhancements and efficiencies
Consistently complies with all governing laws, regulations, Parexel and client SOPs and other guidelinesQualificationsSuccessful candidate will have:
Previous experience in a clinical regulatory affairs focused role in industry.
Graduate (Bachelors) Degree required (life sciences disciplines strongly preferred)
Average of 5 years relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development, submission requirements and Health Authority interactions.
Knowledge of GxP, ICH, and other regulatory guidelines.
Knowledge of the drug development process and how other functions contribute.
Fully competent in teamwork/collaboration, achieving results, regulatory knowledge, operational excellence and organized.
Previous oncology is strongly preferred; however, exceptional candidates with other TA experience will also be considered.
Strong regulatory program management, leadership, teamwork, and communication skills.
Strong verbal and writing skills; proficient in MS Office apps.
Past experience supporting IND/NDA/BLA maintenance, supporting filings (INDs, BLAs, NDAs), supporting FDA meetings, supporting post marketing activities, representing regulatory at study team meetings, and coordinating answers to regulatory questions.
A successful candidate also has:
Impeccable ethics. Demonstrates, or has proven abilities to demonstrate, high values & leadership competencies
Outstanding attention-to-detail and accuracy
Working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g., clinical development, clinical operations, biostatistics, commercial operations, etc.
Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on target and within-budget accomplishment of such
Good interpersonal, verbal communication and influencing skills: can influence without authority in a matrix setting
Strong written communication skills
Good business presentation skills: is comfortable and effective when presenting to others, internally and externally
Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
Works well within teams and is effective in collaborating with others internally and externally
EEO 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..