Celebrating over 50 years of serving medical writers in the Delaware Valley

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Principal Medical Writer
Location: PA or NJ - In-House
Salary: 100,000-130,000
Visit website for more information.

• Prepare and finalize basic and complex scientific/clinical documents as assigned with minimal supervision. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance's, clarity, and accuracy, with attention to format and consistency using established templates. Documents must be prepared within established timelines and in accordance with internal processes.
• Make decisions that impact data interpretation and presentation in documents that will be viewed by external authorities.
• Decide on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges.
• Provide guidance to team with regard to content as appropriate, as well as processes, timelines, and scientific integrity.
• May provide guidance to contractors and oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• May manage the work of document/project team members without authority over them.
• Work collaboratively in a team environment with minimal direction and take a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking, as appropriate.
• Contribute scientifically and strategically and may lead submission-level, strategic activities for writing team.
• Proactively identify opportunities for greater productivity and participate in finding flexible solutions.
• Demonstrate excellent listening skills and be proficient at sending clear, convincing, and well-tuned messages through a variety of media including but not limited to business discussions (one-on-one or larger groups) and e-mail messages.
• Negotiate with and influence others with regard to scientific content and processes.


Primary Responsibilities:
• Contribute scientifically and strategically and may lead submission-level, strategic activities for writing team.
• Proactively identify opportunities for greater productivity and participate in finding flexible solutions.
• Demonstrate excellent listening skills and be proficient at sending clear, convincing, and well-tuned messages through a variety of media including but not limited to business discussions (one-on-one or larger groups) and e-mail messages.
• Negotiate with and influence others with regard to scientific content and processes.

Education Requirements:
Qualifications
• Bachelor's degree with a minimum of 7 years of relevant medical writing experience is required OR a Master's degree or equivalent advanced degree with a minimum of 6 years relevant medical writing experience is required OR a PhD or equivalent with a minimum of 5 years of relevant medical writing experience is required

Experience:
• Strong scientific/medical writing skills including the ability to interpret and organize scientific data is required
• Experience in writing clinical regulatory submission documents, such as Clinical Study Reports, Investigator's Brochures, Clinical Study Protocols, CTD Summary Documents (i.e., Efficacy and Safety Summaries, Clinical Overviews, etc.), Responses to Regulatory Questions, Briefing Documents, and safety documents such as Risk Management Plans, etc. is required
• A working knowledge of clinical study design and biostatistics is preferred
• Experience in using applicable word processing (i.e., MS Word, etc.) software is required
• Experience working on cross-functional teams is required
• Project management experience is preferred
• In-depth knowledge of writing guidelines (e.g. ICH, FDA, AMA, etc.) used for the preparation of clinical documents is required
• Oncology therapeutic area experience is preferred
• Knowledge of the end-to-end drug development process is required

Application Instructions:
EMAIL A WORD COPY OF YOUR RESUME TO abs@kaztronix.com


Website: Visit website for more information and/or to apply.

About the Organization:
Pharmaceutical Company

Contact Information:
Alan Slate | | abs@kaztronix.com

Listing: ID# 35 - 5/2/2017 - 6/15/2017
Posted: 5/1/2017