Medical Writer Opportunity in United States | Fully Remote Job 2023

Rate Range: $60-$80/Hr.

Medical Writer Job Description :

Responsibilities:

• Develop strategic medical writing plans in accordance program and/or project objectives. Plans are developed in accord with applicable guidelines (ICH, CFR, etc.) and with adherence to SMPA templates and SOPs.
• Determine resource requirements to meet regulatory submission document deliverable milestones and timelines in accordance with medical writing plans.
• Manage and provide mentorship and guidance to Medical Writing staff (internal/external) to ensure document development activities are performed in accordance with medical writing plans.
• Provide senior level review of regulatory submission documents prepared by Medical Writing staff (internal/external).
• Author and review documents for regulatory submissions (protocols, investigator brochures, clinical study reports, and IND and NDA summary documents) in support of the clinical development lifecycle and program goals for one or more CNS clinical development programs.
• Drive document strategies and messages to relevant subject matter experts to ensure appropriate, factual and concise presentation of assigned documents.

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Key Core Competencies:

• Excellent problem-solving skills.
• Ability to work effectively on cross-functional teams.

Excellent communication skills:

• Demonstrated ability to understand broad concepts and translate these into medical writing strategy.
• Demonstrated coaching skills to develop individual medical writers.

Education and Experience:

• Bachelors degree required; advanced degree (Masters) in science desired.
• Minimum 8 12 (w/o Masters) or 6 8 years (with Masters) years of relevant experience in biotech or pharmaceutical industry.
• Medical writing experience, including writing and review of documents to support the clinical development life-cycle from IND to NDA and beyond.
• Experience representing medical writing on cross-functional teams.

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About ApTask:
Join ApTask, a global leader in workforce solutions and talent acquisition services, as we shape the future of work. We offer a comprehensive suite of offerings, including staffing and recruitment services, managed services, IT consulting, and project management, providing unparalleled opportunities for professional growth and development. As a member of our dynamic team, you’ll have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success for our clients across diverse industries. If you are passionate about excellence, collaboration, and innovation, and aspire to make a meaningful impact in the world of work, come join us at ApTask and be a part of our mission to empower organizations to thrive.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

Candidate Data Collection Disclaimer:
At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

If you have any concerns or queries about your personal information, please feel free to contact our recruitment team at businessexcellence@aptask.com .