Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!
Proclinical is seeking an experienced and dynamic Sr Manager to give leadership support in the development and delivery of high-quality clinical and regulatory documents. This role involves collaboration to ensure compliance with global standards, consistency in scientific messaging, and timely documentation to support clinical development and regulatory submissions.
Responsibilities:
- Define and implement medical writing strategies across multiple clinical programs.
- Collaborate with Regulatory Affairs, Clinical Development, and Safety teams to align submission planning and timelines.
- Oversee, mentor, and develop medical writing team members and project leads.
- Oversee outsourced medical writing activities, ensuring quality and timely delivery.
- Author and review clinical and regulatory documents, ensuring adherence to internal standards and regulatory requirements.
- Manage multiple projects, balancing timelines, scope, and resources effectively.
- Contribute to process improvement initiatives, including the development of tools, templates, and workflows.
- Communicate complex scientific information clearly to diverse audiences and provide constructive feedback to team members.
- Promote compliance with health, safety, and environmental requirements, ensuring adherence to internal procedures.
Key Skills and Requirements:
- Background in Life Sciences or related discipline; advanced degree preferred.
- Expertise in medical writing within pharmaceutical or CRO environments.
- Experience leading regulatory writing for major submissions (e.g., marketing applications).
- Strong understanding of ICH guidelines, GCP, and global regulatory requirements.
- Proven ability to manage teams and external vendors in a matrixed or global setting.
- Excellent leadership, organizational, and time-management skills.
- High standards for data integrity, quality, and compliance.
- Professional medical writing certification or training is advantageous.
- Fluent in English, both written and verbal.
If you are having difficulty in applying or if you have any questions, please contact Ash Aravindhan at a.aravindhan@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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