Leads medical writing and editing projects for the Early and Late Stage Clinical Development organizations, partnering closely with key stakeholders: Clinical Science Leaders (CSLs), Medical Directors, Clinical Scientists, and protocol authoring teams.
- Oversees the development of protocols, including drafting, editing, coordination of review, adjudication of review comments, and creation of project timelines.
- Acts as a key strategic thinking partner for the clinical scientist and other team members on protocol development and the above deliverables.
- Is a key strategic participant in project teams and committees.
- Acquires and demonstrates a deep understanding of needs for the clinical science organization.
Who you are
- Eight (8) or more years of medical writing and clinical project management experience, preferably in the biotech/Pharmaceutical industry
- Masters or PhD degree in the biological sciences or liberal arts preferred or equivalent experience.
- Superb written and oral communication skills, with a proven ability to communicate effectively with all levels in the organization.
- Demonstrated experience in clinical and nonclinical document preparation and finalization.
- Strong project management and team facilitation skills.
- Demonstrated ability to collaborate and negotiate business solutions in a complex and fast paced matrix environment.
- Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
- Strong analytical and problem solving skills, paired with strong partnering and performance consulting skills.
- Ability to work independently and as part of a team.
- Strong planning and organizational skills, including ability to prioritize and organize high volume workflow and follow a project through to completion, ensuring attention to detail, and highest level of accuracy within required timeframe.
- High degree of customer focused sensitivity towards both internal and external customers and business partners.
- Position may require approximately 5% international travel.
Roche is an equal opportunity employer.Research & Development, Research & Development > Research