Job Opening
Date: March 31, 2008
Title: Senior Medical Writer
Level: 2
Reports to: Senior Manager, Regulatory Medical Writing
Department: Clinical
Summary of Job:
The Senior Medical Writer is responsible for timely preparation of protocols, investigator's brochures, clinical study reports, and integrated summaries, ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. The Senior Medical Writer must be highly self-motivated and experienced in working with CROs and contract writers.
Essential Duties and Responsibilities:
- Responsible for preparation of protocols, investigator's brochures, clinical study reports, and annual reports. May also be responsible for sections of INDs/CTDs and other regulatory documents.
- Serve as primary author or manage the medical writing process when the writing is contracted out to a CRO or contract writer.
- Must be able to analyze complex clinical data and effectively communicate its significance.
- Must have a strong working knowledge and understanding of related ICH guidelines and regulatory requirements.
- Be able to facilitate document review, function as the primary medical writing lead at document review meetings, and incorporate diverse feedback into a high quality document.
- Must be able to function independently with minimal guidance as well as work effectively in a team setting.
- Must have strong organizational and problem solving skills.
- Responsible for ensuring that documents meet the requirements for electronic submission.
Job Requirements:
Education:
- BA/BS minimum requirement with at least 5 years relevant writing experience or equivalent, or an advanced degree with at least 2 years relevant writing experience. AMWA certification a plus.
Experience:
- Proficiency with MS Word, MS Office, Excel.
- Clear understanding of clinical development, including phases, processes, and techniques used within clinical development from protocol design through regulatory submission.
Other Skills and Abilities:
- Excellent written and verbal communications skills.
- Demonstrate initiative and ability to deal with complex situations.
- Ability to lead multiple concurrent writing projects.
- A team player with proven experience building positive work relationships.