Location: India – Chennai
Responsibilities
- Communicate WWS’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
- Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.
- Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
- If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team.
- Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.
- Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs.
- Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
- If assigned by manager, serve as the WWS ‘point of contact’ for all document issues for a given product or set of products.
- Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line.
- Education:
- Bachelor’s Degree in life sciences and 3+ years’ relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas
- Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant field)