• Prepare and finalize clinical and/or regulatory documents such as, but not limited to, nonclinical and clinical study protocols, protocol amendments, Investigator's Brochures, regulatory briefing documents, health authority responses, IND summaries (i.e., Module 2), nonclinical and clinical study reports, charters, statistical analysis plans and pediatric documents
• Lead cross-functional document planning and review meetings. Interact with peer writers and cross-functional team members. Able to lead program-level or submission writing teams with supervision. Able to lead process working groups
• Coach or mentor cross-functional partners on document planning, processes, content, and provide peer review as needed
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and input from cross-functional team members, as needed
• Be the primary point of contact and champion for medical writing activities.
• Responsible for planning, setting strategy, and leading writing group for assigned program
• Maintain and apply knowledge of the industry, company, and regulatory guidelines

What we’re looking for 

• University/college degree required
• At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years of relevant medical and regulatory writing experience; experience with all stages of development is preferred
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision, with input from cross-functional team members, as needed
• Strong attention to detail
• Strong oral and written communication skills
• Strong leadership skills, both in time management as well as in project/process management
• Able to resolve complex problems under general supervision
• Demonstrate learning agility
• Able to build solid and positive relationships with cross‐functional team members

What you should know 

• Masters or PhD preferred
• The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience