Thank YOU, and I appreciate YOU for expressing interest in this posting ! ... Please take NOTE and make sure that YOU match ALL the Job Specifications outlined below ... My Client has very Specific Requirements ... Please understand these are very $ HIGH PAYING $ positions and so Criteria matching is crucial for YOUR Placement ! ... We recognize that the foundation for providing excellent service begins with recruiting exceptional candidates, cultivating YOUR talents, and Integration with our Client ...
Principle Clinical Writer
Pharmaceutical / Biotech
Artistic - Documentation / Technical Writing
United States - North Carolina - Durham
Benefits - Full
Relocation Assistance Available - Yes
Commission Compensation - No
Bonus Eligible - Yes
Overtime Eligible - No
Interview Travel Reimbursed - Yes
Responsible for the preparation and filing of regulatory documentation associated with Phase 1-3 studies of drug/biologic products. Works closely with the clinical, pre-clinical and Chemistry, Manufacturing, and Controls personnel. A key responsibility will be contemporaneous review of safety and efficacy data, interpretation and communication of results from pre-clinical and clinical studies, as well as, generated data in support of regulatory submissions.
- Prepares Investigational New Drugs (IND's), IND amendments, New Drug Application/Biologics License Application/Marketing Authorization Application (NDA/BLA/MAA), regulatory filings, inclusive of any pre-meeting materials with global Health Authorities, partners, or industry experts.
- Involves working with and leading project teams to prepare clinical and related documentation such as protocols, study reports, and Investigator Brochures.
- Ensures the quality, content, and format of regulatory submissions comply with applicable regulations and guideline.
- Ensures consistent style of presentation of documentation to facilitate Health Authority review.
- Interfaces with Health Authorities to facilitate timely review and approval of submissions. Coordinates activities to address any deficiencies received on documentation submitted to Health Authorities.
- Utilizes Company's Document Management System and related tools, templates, and procedures to ensure efficient publishing of documents and dossier in accordance with required formats, such as electronic Common Technical Document (eCTD).
- Travel - Domestic up to 10%
- Requires a Bachelor's degree in a scientific discipline. A Master's or Ph.D. degree in life science, medicine, or related field preferred.
- A minimum of 7 years' experience in Quality and/or Clinical with the Medical Device Industry and/or Pharma Industry.
- Minimum of 5 years' experience as a medical writer. Proficiency in eCTD document preparation preferred.
- Abilities to review/analyze relevant data so as to build evidence-based strategies.
- Strong computer skills with an ability to understand, access and leverage technology alternatives
- Ability to work both independently and collaboratively with a team.
- Demonstrated leadership and ability to prioritize tasks to complete high quality documents in accordance with prescribed timelines.
More About the Position
Visa Candidates Considered - No
7+ to 10 years of experience
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Candidate Screening Questions
Does the candidate have 7 years’ experience in Quality and/or Clinical with the Medical Device industry and/or Pharma industry?
Does this candidate have 5 years’ experience as a medical writer?
Does your caniddate have an MBA or Ph.D? It is preferred?
Does the candidate have a BS in Scientific field? It is required.