Meet is currently working alongside one of Boston's most up-and-coming Biotech companies. Working on developing industry leading Cancer Vaccine and RNA technologies & therapies, this Biotech has a cutting edge pipeline of groundbreaking products. This client is now seeking a Clinical Medical Writer to join their team and serve as the key lead medical writer on all regulatory documents. This will be a very hands-on, cross-functional position where this individual will have great oversight and leadership responsibilities.
• Prepare, manage, and develop high quality clinical document deliverables in a timely manner. Such documents include but are not limited to: clinical protocols, clinical study reports, investigator brochures, and regulatory submissions including briefing books
• Negotiate timelines, implement SOPs, and take responsibility for excecution across cross-functional teams
• Involvement in building out and heading up an in-house medical writing department
• Review, edit, and quality check documents or sections of documents written by internal and contract writers
• 5+ yrs of hands on regulatory/clinical writing experience combined with relevant pharmaceutical industry experience
• Regulatory knowledge and experience with regulatory submissions and global trials
• Basic project management and organizational skills, and strong prioritization skills for the management of multiple concurrent projects
Full job description and company details are available upon application. This position is being dealt with by Meghan McCann at Meet Recruitment, call on +1 646-569-9081 or email directly at firstname.lastname@example.org to discuss further and in confidence.
You can find out more about Meghan and Meet at www.peoplewithchemistry.com