Medical Writing Project Manager - Remote

Description:

Medical Writing Project Manager

Job Summary

Develop detailed, strategic and tactical plans for medical writing documents in partnership with the medical writers (in-house and contract), cross functional teams, and program management to meet agreed submission timelines. These documents/projects include, but are not limited to, CSRs, protocols, IBs, submission summary documents, clinical pharmacology documents (ie, those that medical writing supports), risk management plans, and regulatory briefing and response documents. Partner with the Head of Medical Writing on resource planning and tracking, using tools and templates.

The project manager plays a crucial role in effectively and efficiently managing project execution by liaising between teams. Enables medical writers to focus on value-added content, creative thinking, and developing quality documents

The project manager will play a key role in supporting medical writers from document conception to completion.

Essential Functions

Support Oncology activities and deliverables through developing, maintaining, and finalizing document project plans, including for regulatory submissions. Track deliverables in partnership with the medical writers and crossfunctional teams to ensure timely document completion. Revise MW document project plans as appropriate to meet changing needs and requirements as directed.

Develop and maintain document plans through close communication with the medical writers, QC reviewers, crossfunctional teams, and document coordinator, regarding updates to timelines (including QC and publishing plans). Assist with document team and reviewer list development and maintenance and document review scheduling.

Maintains OBG MW department resource planning tracker.

Develops and maintains effective tools and templates to ensure clearly defined timelines and project plans.

Prepares and submits project status reports to teams and to management. Conducts regular project status update meetings.

Coordinate production and delivery of multiple documents by building detailed project plans and timelines and then following through on these plans. Document scope changes and the impacts to timelines and budgets

Initiate or support the initiation of kickoff meetings

Orchestrate QA/QC, tracking and approvals

Proactively identify project risks and in conjunction with team members, develop avoidance and mitigation plans

Facilitate conducting team meetings that have structure and clear purposes and goals.

Facilitate and drive meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team.

Requirements:

BS or BA; advanced degree desirable. Minimum of 5+ years of pharmaceutical or medical device industry experience

Project management and organizational skills. Experience in the use and understanding of the critical value of technology in planning, managing milestones and integrating interdependencies within an organization. MS project experience required. PMP certification a plus.

Knowledgeable in domestic and international guidelines, policies and regulations; GxPs; submission/registration types and requirements

Strong knowledge of clinical research document process flows and how the individual document types fit into a submission filing. Experience working with medical writers or as a medical writer preferred.

Ability to work effectively in a virtual setting/across time zones with remote/hybrid, global teams (ie, making effective use of communication tools (video conferencing, etc.)

Strong planning and organizational skills

Well-developed analytical and problem-solving skills, and high attention to details

Ability to effectively work with teams and promote collaborations in a matrix organization. Exceptional interpersonal skills including ability to persuade, negotiate and resolve conflicts.

Excellent verbal and written communication skills, ability to interact with various levels of management within the organization and to external collaborators.