Senior Project Manager Medical Writing

Short Description

We are looking for an experienced professional, able to boost medical writing for Clinical Evidence and being a prominent face for surgeons in our Innovation Translation Center (ITC).

Main Responsibilities

Team Management

• Team Leadership : Strategize medical writing team with two direct reports. Resource management overseeing distribution of tasks within the team, project progression and ensuring timely delivery within the budgetary framework
• People development : Supervise, mentor, support individual development, and provide guidance to two medical writers. Conduct performance evaluations, provide feedback, and identify training and development needs for the team.

Motivating and fostering team coherence

Strategic Contribution : Contribute to the development of medical writing strategies and best practices. Identify opportunities for process improvements and implement changes to enhance productivity and quality.

Assure team knowledge of quality standards and adherence of SOPs

Research and Medical Writing

• Lead the core medical writing activities, independently developing high-quality medical content for our stakeholders (eg, original research manuscripts, reviews, final study reports, digital content and other clinical research documents) within and beyond AO ITC
• Writing content that meets surgeons' needs, anticipates these needs and supports client's decision making. Building relationship with our clients based on outstanding writing and knowledge, being an invaluable scientific and strategic partner for clients
• Working to highest levels of quality and accuracy on any given project, using multiple writing styles and adapting as needed
• Support research and educational activities from other AO units in accordance with AO ITC's value proposition

Communication

• Stakeholder Communication : Liaise with internal stakeholders and external clients to understand project requirements and expectations
• Communicate and promote results through internal and external channels and increase the visibility of clinical evidence generated at the AO ITC
• Define, lead, and support AO ITC's marketing and communication needs
• Liaise with the AO ITC business units and AO communication department in support of the marketing and communication needs of AO ITC

Quality management

• Process owner of medical writing related guidelines, SOPs, and templates
• Maintenance of medical writing related documents

Main Requirements

Specific Requirements

• Advanced degree in biomedical fields (Ph.D., Pharm.D., M.D., or equivalent preferred)
• Minimum of 5 years of experience in clinical research, preferably in orthopedics
• Well versed in clinical study design, GCP, regulatory standards, and clinical research methodologies and standards (meta-analysis, GRADEpro, EQUATOR checklists, consensus process, etc)
• Experience managing a smaller team
• Strong analytical, statistical and research capabilities. Experienced in reviewing study protocols and database
• Excellent written and verbal English

Generic Requirements

• Strong organizational and project management skills.
• Leadership skills : Motivating collaborators, Independent decision making and implementation, Handling complex problems, thinking on the feet
• High level of attention to detail and commitment to producing high-quality work
• Responsible and reliable; adhering to deadlines
• Team orientation and ability to navigate a complex organization
• Excellent presentation and communication skills
• An interesting and varied job in an exciting and innovative organization
• The opportunity to be part of a highly committed international team
• Modern infrastructure
• High degree of flexibility regarding working hours and location (depending on operational requirements)
• Generous pagacke of social benefits, including supplementary vacation days and pension scheme contributions
• Internal skills training opportunities and support for continued education
Vor 16 Tagen