 
As a Medical Writing Specialist, you will be responsible for performing complex medical writing tasks and acting as a project manager. This role involves planning, developing, and overseeing regulatory documents across all phases of clinical development, including Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Meeting packages, Investigator Brochures (IB), Regulatory response documents (Q&A), Clinical summaries, and Clinical overviews. You will set direction, drive discussions, ensure decisions are made, and influence and implement project strategies.
Key Responsibilities:
- Communicate clinical data clearly and concisely.
- Contribute to process improvements, knowledge sharing, and skill building.
- Mentor and train other medical writers as needed.
- Maintain good relationships with stakeholders and colleagues.
- Ensure timely, clear, and proactive communication and collaboration with stakeholders and colleagues globally.
- Assume the roles of Project Medical Writer (PMW) and Clinical Submission Team Lead (CST) for assigned projects.
- Meet timelines by planning work effectively and being proactive when problems arise.
- Support the execution of Clinical Reporting strategy and vision in line with the leadership team.
- Challenge expert contributors to improve the quality of their written contributions.
- Ensure the accuracy and compliance of documents with regulatory standards and guidelines.
Qualifications:
- Graduate degree (PhD, MSc., M Pharm, or equivalent).
- ≥10 years of experience as a medical writer or other relevant work experience.
- Experience in regulatory medical writing, including Clinical Study Reports (CSR), protocols, Investigator Brochures (IB), informed consent forms, clinical summaries, and clinical overviews.
- Excellent understanding of clinical development and regulatory processes and requirements.
- Experience working in a global setting and in the pharmaceutical/CRO industry.
- Strong analytical skills and excellent communication and presentation skills.
- Committed, persistent, and accountable with the ability to handle numerous tasks simultaneously.
- Demonstrated ability to identify best practices and create improvements in methods, techniques, and approaches.
- Proven track record of being a proactive team player and delivering high-quality work on time.
