Pharmaceutical Clinical Associates, LLC
-
Springfiled,
NJ
Prerequisites:
· Completed BS/BA degree in Biomedical Science required (Masters preferred); and
· Must have 7+ years in the pharmaceutical industry or in a CRO, including 3+ years of writing experience.
Summary
Responsibilities include:
1. Provide leadership, strategic planning & effective management and guidance to all
functional areas within Global Scientific & Medical Writing. Liaise with Japanese Medical
Writing to effectively manage global regulatory submission documents.
2. Manage the performance of Global Scientific & Medical Writing personnel who are
responsible for the planning, authoring, compilation, review and approval of global regulatory
submission documents (protocols, amendments, briefing books, investigators brochures,
clinical study reports and summary documents).
3. Provide leadership to the global community in developing & managing existing standards,
processes & practices. Ensure continuous improvement of these processes & practices.
Ensure proper and timely training to optimize the introduction and implementation of new
workflow processes and technologies.
4. Manage the Global Scientific & Medical Writing groups (medical writers, quality control and
document processing & coordination) and assure regulatory compliance and adherence to
GCP standards. Must participate actively in all activities necessary.
5. Develop a strong Global Scientific & Medical Writing group across multiple domestic &
international sites. Develop & coach subordinates to assure timelines are met and conflicts
are resolved quickly.
6. Liaise with CROs and independent contractors to define tasks, monitor performance, and
provide direction. Evaluate medical writing consultants with regard to processes, SOPs, and
global templates. Manage support for medical writing activities outsourced to CROs and
independent contractors.
7. Build strong external network with professionals in the pharmaceutical industry.
Experience and Skills:
Skills/Knowledge Required:
• Extensive knowledge of health authority regulations, policies, and guidelines pertaining to
global dossiers.
• Extensive knowledge of GCP requirements and the drug development process.
• Demonstrated experience in strategic and multi-project planning, including resource
allocation and budgeting.
• Demonstrated experience in fostering and managing external writing resources (i.e.,
independent contractors, CROs).
• Excellent written and oral communication skills.
• Excellent organizational skills.
• Expert level with electronic templates and complex documents.
• Expert level with document repository management applications (e.g., eSub, Livelink).
• Expert level with MS Word including table functions and working with styles.
Competencies:
Thinks Strategically
Manages Execution
Leverages Networks
Leads Courageously
Influencing Others
Motivates Others
Fosters Teamwork
Effective Speaking
Fosters Open Communication
Displays Organizational Savvy
Focus on Customer Needs
Coaching and Developing Others
Provides Directions
Structuring and Staffing
Sprig
Additional Information:
Job Level: Executive
Number of Openings: 1
Years of Experience: At least 7 Years
Level of Education: Masters Degree
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Springfiled, NJ
Springfiled, New Jersey
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