Medical Writer

Our client, a leading Pharmaceutical company is hiring a Procedural Medical Writer on a contracting basis.

Work Location: Lawrenceville NJ

Job Description: Procedural Document Writer

Expected Areas of Competence:
• Ability to develop a range of written materials such as detailed instructions for high level principles-based documents
• Demonstrated ability to write complex processes in a logical order using simplified language, creation of visual process flow diagrams, and information mapping techniques
• Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape
• Ability to effectively manage projects, escalate issues as necessary and meet key milestones
• Ability to lead and facilitate writing team meetings, that contribute to attaining team goals and resolving complex issues
• Ability to evaluate utility of documents and assemble content to ensure clarity for users (including those who are not native English speakers)
• Collaboratively work with Regulatory and Clinical colleagues to ensure any process changes resulting from the issuance of new or revised GCP/ICH Guidelines, regulations, and other guidelines applicable to clinical research are documented appropriately, in an appropriate format
• Work with autonomy and is able to able to negotiate and influence others without direct authority

Qualifications:
• Bachelor’s degree with a minimum of 5-10 years experience in global drug development
• Demonstrated knowledge of Good Clinical Practice (GCP) ICH
Guidelines and applicable FDA regulations
• Project Management:
o Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
o Demonstrated ability to maintain a high level of productivity, accountability and energy
o Demonstrated success in managing project team effectiveness, through facilitation and presentation skills to a globally diverse audience
• Document Development and Review:
o High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper
o Provides close attention to detail and excellent follow up
o Ability to take very detailed information and distill it down to focus on key messages
• Flexible thinker with a growth mindset
o Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
o Affinity towards fully utilizing technology

Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.

Regards,
Devan Patel
Technical Recruiter
646-668-4247
dpatel@tsrconsulting.com