Job Description

Job Description:

We are seeking a highly motivated, well-organized, and skilled Principal or Senior Manager of Medical Writing to develop clinical and regulatory documents in collaboration with internal and external stakeholders, and apply critical thinking, principles of scientific writing, data interpretation, and knowledge of regulatory content life cycle.

What You’ll Do

•Lead the preparation of clinical and regulatory documents (eg, protocols, investigator brochures [IBs], safety updates, clinical study reports, IND/NDA/MAA CTD submission documents, briefing documents, and responses to regulatory authority questions) in accordance with applicable global and regional regulatory guidelines, and Company partners’ standards/SOPs

•Plan content in partnership with functional leads and create timelines for development of assigned documents

•Responsible for organization, clarity, scientific standards, formatting, and consistency of content within and across all documents for a program or within a clinical dossier

•Lead document adjudication meetings and resolve issues with cross-functional contributors

•Manage the review and approval process, including liaising with development partners

•Work independently and effectively with cross-functional, geographically and culturally diverse teams, and establish strong collaborative relationships by creating an atmosphere of openness and trust

Requirements

•Bachelor’s degree in life sciences; master’s or doctorate degree in life sciences preferred

Minimum of 8 years of direct medical writing experience in biopharmaceutical industry or related CROs with at least 3 years of experience in drug development in oncology

•Demonstrated ability to produce clear, high-quality writing in the English language AND demonstrated experience in the preparation of a broad range of complex clinical and regulatory documents and global submissions

•Experience with the planning, authoring, review, and approval of protocols, DSURs, IBs, and IND/NDA/MAA CTD submission documents

•Strong project management and team facilitation skills to lead complex projects in a fast-paced matrix environment

•Ability to influence without authority and foster the productive exchange of ideas amongst colleagues

•Experience managing projects of increasing scope and complexity

•Understanding of the interdependencies of various contributing functions (eg, clinical

Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment and competing priorities

•Highly effective communication skills and the ability to present ideas and data clearly to a group, including key stakeholders at a senior level

•Familiarity with approaches to expedite document preparation, such as review tools and automation

•Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective solutions

•High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data

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