Senior Medical Writer - Oncology

Job Description

Position Description:

Senior Medical Writer

The Senior Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:

• Demonstrates independence in preparing clinical regulatory documents (e.g., protocols, clinical study reports, investigator’s brochures, clinical sections of submissions) per company and regulatory requirements.
• Applies an in-depth knowledge of medical writing responsibilities, including document planning and authoring, and interpretation of data.
• Is a scientific contributor and works collaboratively on document-specific cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.
• Applies knowledge of clinical development, relevant regulations, disease areas, and company products.
• Applies critical thinking, problem solving and negotiation skills to identify innovative solutions to challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.
• Applies knowledge of medical writing-specific tools and technology platforms.
• Participates in or leads initiatives to improve medical writing processes and standards.
• May participate in orientation and coaching of junior team members or contract writers.

Position Qualifications:

Education Minimum Requirement:

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).
• Bachelor’s degree with 5+ years, master’s degree with 4+ years, or doctorate degree with 3+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.

Required Experience and Skills:

• Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., clinical study reports, investigator’s brochures, clinical sections of submissions) per regulatory requirements and industry guidelines.
• Ability to present clinical data clearly and objectively, with minimal supervision.
• Demonstrated critical thinking and problem-solving capabilities.
• Ability to manage multiple projects in a deadline-driven environment, work collaboratively, and lead authoring teams of medical writers and cross-functional members.
• Excellent oral and written communication and presentation skills.
• Technical expertise in office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint); familiarity with concepts of structured content management preferred.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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