Job Title:
Medical Writer Manager or Associate Director
Full Time, Northern NJ
Job Description:
This position will be In-house 5 days a week.
Telecommuting will not be an option.
Responsibilities will include, but are not limited to, the following:
1. Provide medical writing support for correlative Translational Development studies, report components and stand alone reports.
2. Prepare quality documents that are timely and are consistent with the needs of the clinical report.
3. Establish the process for the review of these documents.
4. Co-develop the strategy for document preparation, SOPs, and guideline documents including time frames that meet or exceed company standards and the document review processes.
5. Prepare content templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines.
6. Facilitate key message and document review meetings and discussions.
7. Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation as needed.
8. Gather data, QC data and review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation and prepare such data outputs.
9. Effectively partner with statisticians in Clinical R&D, translational scientists in Translational Development, data analysts in Research Information Systems, specialists in RegOps and Clinical Quality Assurance to prepare and execute Translational Medicine projects while complying with regulations applicable to global drug development including all corporate SOPs and ICH/GCP guidelines 10. Facilitate meetings with TD, PK, Clinical, Stats, Bio-informatics to review and derive meaning of data.
11. Participate in the preparation of possible journal submissions.
Skills/Knowledge Required:
• Knowledge of FDA and ICH guidelines
• Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use
• Knowledgeable in preclinical development including discovery, toxicology etc.
• Ability to work with complex projects and within cross-functional teams
• Experience working with CROs
• Expertise in multiple therapeutic areas
• Excellent grammatical and communication skills, both written and oral
• Expertise in MS WORD, including the ability to solve technical problems with WORD templates
Contact: Laura Walton at (201) 793-1006 lwalton@aerotek.com
