Senior Medical Writer/ Manager

il y a 5 heures


Zaventem, Belgique LivaNova Temps plein

Join us today and make a difference in people's lives

The Medical Writer prepares clinical evaluation plans (CEP) and reports (CER), Post Market Clinical Follow-up (PMCF) Plans and Reports, and performs ad hoc and systematic literature reviews.

At a manager level, the Medical Writer Manager:

- prepares clinical evaluation plans (CEP) and reports (CER), Post Market Clinical Follow-up (PMCF) Plans and Reports, and performs ad hoc and systematic literature reviews
- manages a small team of internal and external medical writers
- manages the medical writing project schedule and deadlines
- provides strategic decisions on projects in the medical writing program.

In this role you will have to:
1. Ensure completion of clinical evaluation plans (CEP) and reports (CER) and Post Market Clinical Follow-up (PMCF) Plans and Reports per each product family within the Cardiac Surgery (CS) franchise in cooperation with all main internal and external stakeholders within the agreed timelines.

2. Perform ad hoc and systematic literature reviews on global scientific newly released data to support Product Market Surveillance reports, Global Signal Detection meetings, Study Design Protocols, Global Market Value Dossiers, Regulatory Dossiers, Medical Affairs scientific summary documents.

3. Provide writing skills to protocols and clinical study reports and all relevant clinical documentation (literature review plans/reports; study protocols/reports; scientific manuscript; congress abstracts/posters/presentations).

4. Collaborate with cross-functional teams to develop clinical evaluation strategies.

At a manager level, the Medical Writer Manager will:

- prepares clinical evaluation plans (CEP) and reports (CER), Post Market Clinical Follow-up (PMCF) Plans and Reports, and performs ad hoc and systematic literature reviews
- manages a small team of internal and external medical writers
- manages the medical writing project schedule and deadlines
- provides strategic decisions on projects in the medical writing program

Knowledge, skills and essential background:
Previous experience in medical writing/reading. Understanding of the impact factor and relevance of scientific journals and papers.

Strong skills in data statistics and study design.

Industry experience that includes the understanding of Clinical Development, Regulatory Affairs and Marketing activities, through different stages. Understanding of the international guidelines, US and European.

Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment. Efficient writing of large documents per project deadlines.

Ability to work well with a diverse group of personalities, team player, flexible and adaptable; ability to build relationships, both internally and externally to the organization.

Excellent English oral and written (C2); excellent oral communication and medical writing skills.

Familiarity with industry-wide good publication practices.

Minimum of Bachelors (4 year university) degree. Graduate degree preferred.

Biomedical or medical or pharmaceutical industry degree is preferred, or a strong expertise in medical device.

Proven relevant experience in areas such as medical or clinical research activities (eg, clinical trial management support, data management, submission dossier, Clinical Study Reports, etc.)

Willingness to travel: up to 25% of the job may be travel

Our commitment to Diversity & Inclusion:

- LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination._

Background Checks at LivaNova:

- Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check._

Notice to third party agencies:


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