Senior Medical Writer
Proclinical is currently recruiting for a Senior Medical Writer for a pharmaceutical company located in Boston, MA. Successful candidate will be responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines.
- Represents medical writing for all clinical studies
- Work with clinical & regulatory teams to produce clinical documents (clinical study reports, protocols/protocol amendments, Investigator Brochures, safety updates, briefing documents, clinical summaries of safety and efficacy and clinical sections of INDs, NDAs, MAAs and other regulatory submissions) within specified timelines
- Manage and communicate timelines with team members and senior management to ensure milestones are met
- Provide quality control review checks of assigned regulatory documents
- Work with team to develop standardization of templates, processes, and tools (SOPs, best practices, templates, style guide)
- Oversee all contract and external medical writing resources
- Ability to compile, analyze and present complex information and data
Skills and Requirements:
- BS/BA and 5 years of experience in regulatory writing within the pharmaceutical industry
- MS/MA and 3 years of experience in regulatory writing within the pharmaceutical industry
- IND/NDA submission experience preferred
- Experience working with an electronic based document management system.
- Experience partnering with regulatory groups and formulating regulatory strategies
- Ability to communicate with cross-functional team members
- Strong understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guideline
- The ability to establish and maintain effective relationships with other management staff, employees, other company affiliates, and the general public
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Merna Hermiz at (+1) 213-293-0932 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.