Lead Medical Writer, Oncology Regulatory Affairs
3 weeks ago
About Us
At myGwork, we are committed to fostering an inclusive environment that supports the LGBTQ+ business community.
Position Overview
We are seeking a Lead Medical Writer to join our Oncology Regulatory Affairs team. This role is pivotal in shaping the future of medical writing within our organization, focusing on innovative solutions that address critical health challenges.
Key Responsibilities:
- Draft and finalize a variety of clinical documentation.
- Collaborate effectively within a team, taking initiative on projects regarding content strategy, timelines, and deliverables.
- Set objectives for team members and lead project discussions.
- Provide guidance and training to cross-functional teams on best practices and processes.
- May oversee project-specific writing teams and ensure quality standards are met.
- Proactively suggest improvements to departmental processes.
- Act as the primary contact for medical writing activities within clinical teams.
- Engage in cross-functional meetings to enhance collaboration.
- Stay updated on industry regulations and guidelines.
- Mentor junior staff in document planning and review processes.
- Facilitate communication with senior colleagues to strengthen interdepartmental coordination.
- Represent the Medical Writing department in industry standards discussions.
- If in a managerial role, oversee direct reports, set performance objectives, and conduct regular development meetings.
Qualifications:
Education: A degree from a recognized university is required; advanced degrees (Masters or PhD) are preferred.
Experience and Skills:
- A minimum of 8 years in the pharmaceutical or scientific field, with at least 6 years in medical writing.
- Experience in oncology is highly desirable.
- Strong attention to detail and exceptional communication skills.
- Proficient in project management and leadership.
- Ability to interpret and present complex medical data accurately.
- Proven problem-solving skills and adaptability.
- Ability to build and maintain positive relationships with team members.
- Familiarity with regulatory guidance documents, including ICH requirements.
We are dedicated to providing reasonable accommodations for individuals with disabilities throughout the application and interview process. Please reach out to us for assistance.
myGwork is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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