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Medical Writing Director
2 months ago
We are seeking a highly experienced Medical Writing Director to lead our clinical documentation efforts. This role will be responsible for overseeing the development of high-quality clinical documents, including protocols, reports, and regulatory submissions.
About Us
Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. We pride ourselves on delivering innovative solutions and exceptional candidate experiences.
Job Description:
Key Responsibilities:
- Lead clinical document development teams, ensuring timely delivery of high-quality documents.
- Collaborate with cross-functional teams, including study teams, regulatory, and pharmacovigilance.
- Develop and implement process improvements to enhance efficiency and quality.
- Manage budgets and resources effectively, prioritizing tasks to meet deadlines.
- Cultivate strong relationships with internal stakeholders, promoting open communication and feedback.
- Stay up-to-date with industry developments, adhering to Good Clinical Practices, FDA regulations, and ICH guidelines.
Requirements:
- 7+ years' experience in Pharmaceutical, Biotech, Academic, or CRO environments.
- Proven track record of medical writing within a relevant therapy area.
- Expert-level written English skills, with ability to present information clearly and accurately.
- Strong diagnostic, analytical, and problem-solving skills.
- Managerial capability with proven leadership profile.
Preferred Skills:
- In-depth knowledge of Good Clinical Practices, FDA regulations, and ICH guidelines.
- Operational project management experience, with excellent planning, prioritization, and organizational skills.
- Demonstrated ability to assimilate knowledge and understanding of new therapeutic areas.
Location:
This role is flexible, allowing for remote work options, with opportunities to work from Ipsen UK or France.
Salary:
£80,000 - £100,000 per annum, depending on experience.
Benefits:
Lifelancer offers a competitive benefits package, including health insurance, retirement plan, and paid time off.