Team Leader Medical Writing

Cerner Enviza an Oracle company is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind
- With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
- Thanks to our Business growth Cerner Enviza is looking for a new talented Team Leader Medical Writing. In this role, you will manage a team Medical Writer and assist them in developing mid
- and long-term growth plans. You will also lead and manage all activities within the medical writing group and thereby ensure that work is performed in accordance with internal SOPs and working practices, ICH and industry guidelines, 21 CFR part 11, and other regulations.
- Recognized as an Expert, the Team Leader Medical Writing will collaborate closely internally with account managers and projects managers to deliver compelling content to differentiate our dynamic and multicultural company from competition and externally with our clients as you will be responsible for overall relationship with the client for work conducted by your team.**MISSION**
- You will review and approve Medical Writing documents and project specifications and provide / supervise Medical Writing budgets and timelines.
- You will participate in new business development activities.
- You will participate in recruitment and performance review of associates.
- You will have 1:1s with team members on a frequent basis.
- In collaboration with the Quality Management you will establish and maintain Medical Writing relevant standard operation procedures (SOPs), job descriptions and training programs.
- You will write, review and edit protocols, reports and other study related documents for clinical studies, non-interventional and (pharmaco-) epidemiological studies and will be involved in preparing manuscripts for publications and posters, modules of the Common Technical Document (CTD) as well as periodic safety update reports (PSUR / PBRER / DSUR).
- You will work effectively with other teams in Cerner Enviza, particularly Data Management and Statistics teams.

**Working Environment**:

- Hybrid & Onsite: No Relocation Assistance OfferedThis position offers a Hybrid & Onsite working environment. Meaning you will split working time between a Cerner office or client site and remote. If your current geographical location requires relocating, Cerner will not offer relocation assistance to the specified location. #LI-Hybrid

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**Cerner Jobs and Careers**:
**Additional Information**:
**Working Environment**
- Hybrid & Onsite: No Relocation Assistance Offered**Relocation Assistance Available for this Job**:

- No**Qualifications**:
**Basic Qualifications**
- Bachelor's Degree or equivalent in a relevant scientific field, higher degrees (PhD/MSc) preferred.
- At least 8 years’ experience as a medical writer.
- You have a strong experience of People management in a matrix organization.
- You have a strong writing experience within a pharmaceutical company or CRO, with a focus on the writing of protocols and study reports according to ICH guidelines and preparation of manuscripts for publication.
- You have a profound knowledge of medical writing and biostatistics.
- You are able to devise and deliver reports in a customer-focused approach as well as within the applicable regulations.
- Fluency English (C2).
- Excellent communication skills - able to distill issues, manage client expectations and act as a trusted advisor in a timely manner.
- Excellent planning, organization skills.
- Ability to work effectively in a team in a fast-paced and dynamic environment.

All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.

Cerner is a place where people are encouraged to innovate with confidence and focus on what is important - people’s health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.
- Cerner’s policy