Principle Medical Writer

Principal (Associate Director) Medical Writer

Massachusetts - United States

Summary:

Seeking an experienced Principal Medical Writer to join a growing pharmaceutical group in the Greater Boston area. You'd be working with a top pharmaceutical company to lead the development and approvals of all clinical regulatory document types.

*This is a permanent position located in MA. Role has some flexibility offering a couple days remote per week; however, you must be local to the MA site and required to be on-site most days.

Responsibilities:

• Lead responsibilities and provide mentorship to other medical writers to ensure quality and effectiveness in the production of all regulatory documents.
• Oversee aspects of program(s) by attending strategy meetings, collaborating cross-functionally with other members or departments, establishing timelines, etc.
• Experience with interpreting and applying global regulatory authorities' regulations and/or guidance.
• You will be responsible for leading, coordinating, compiling and producing routine regulatory submissions/amendments (IND/CTA) on a global scale.
• Must have the ability to lead the development, process, and approval of all regulatory document types and the ability to develop and build document types.
• Working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.
• Interpret and apply global regulatory authorities' regulations and guidance, i.e.: CSRs, IBs, ICH.
• Excellent working knowledge of writing-related computer software, templates, and electronic document management systems.
• You will be responsible for tracking timelines on regulatory deliverables as well as providing project updates - this will include highlighting any risks that might impact the ability to achieve corporate goals.
• Demonstrated ability to appropriately manage resourcing across multiple projects.
• You will ensure that all regulatory submission documents are fully compliant with internal document standards.

Skills & Competencies:

• Strong oral and written communication skills
• Leadership and mentoring skills
• Strong analytical and organizational skills
• Excellent project management skills with proven track record of meeting clinical timelines

Requirements:

• Advanced degree (PhD) in a relevant discipline is highly preferred; Master's degree is required
• 10 years of experience in clinical/pharmaceutical development with 8+ years directly related scientific/clinical regulatory writing experience
• Global regulatory submission experience
• Diverse experience across multiple therapeutic areas, i.e.: Oncology, Neuroscience, CNS, etc.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.