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This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1233313 This individual will contribute to and execute the overall strategy for all medical writing processes according to internal medical writing standards and corporate objectives.

Roles and Responsibilities:

• Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
• Author clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and that complies with applicable company SOPs, style guide, lexicon, templates, and libraries
• May include roles that are key technical or subject matter experts providing professional or thought leadership
• Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectives
• Collaborates with clinical project teams, including program leader, clinical study managers, biostatisticians, medical directors, to ensure project deadlines are met
• Responsible for inspection-readiness of medical writing activities
• Responsible for medical writers assigned to support the medical writing activities for a particular project
• Establishes operational objectives, policies, procedures, and job aids
• Executes corporate objectives, goals, measures, and strategies; and begins to inform the development of them
• May delegate work assessments

Desired Skills and Experience:

• Bachelor\'s degree in a scientific or clinical discipline or related field required; PhD preferred
• Minimum of 5+ years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
• Native/bilingual or fluent American English proficiency
• Familiarity with FDA and ICH guidelines for clinical reporting
• Familiarity with pharmacovigilance documents preferred
• eCTD development, publishing, and submission experience preferred
• Therapeutic experience in biologics preferred
• Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
• Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
• Ability to proofread documents for compliance with internal and external guidance documents
• Ability to approach issues from various perspectives and accurately summarize data to provide conclusions
• Ability to work precisely according to procedures and regulations
• Excellent written and verbal communication skills
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Ability to work autonomously, as well as collaboratively in a team
• Excellent time management skills and a proven ability to work on multiple projects at any given time
• Must be proficient in MS Office

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following l nk into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

Benefits Information:

Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required