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Principle Medical Writer
- Posted 07 February 2020
- Salary Up to US$0.00 per annum
- LocationMassachusetts
- Job type Permanent
- ReferenceBBBH99011_1581112462
- Contact NameBria Gaber
Job description
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.