Arbejde Manager Safety Medical Writing Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Manager Safety Medical Writing

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd We are seeking an energetic and self-driven manager to inspire, set direction, and manage a team of 10 highly professional self-driven safety medical writers specialising in the area of drug safety. If you are the type that likes working in a fast-paced rapidly changing regulatory environment where tight deadlines, effective cross-functional collaboration, and focus of quality and compliance are key elements of the daily work… then this may be the job you are looking for. About the department Safety Medical Writing is a high-performing scientific and dynamic department of 10 engaged professionals ( human biologists, pharmacists, etc.). We are globally responsible for preparing periodic aggregate reports of adverse reactions and risk management plans for all Novo Nordisk products . Medical writers typically work in multi-disciplinary teams, interacting with all major functions across Novo Nordisk. The role of the department is to ensure the timely preparation of high quality scientific documents that are compliant with regulatory guidelines, ensuring ongoing and transparent reporting, evaluation and management of the emerging safety profile of drugs – both while under development and after marketing. With the increasing public focus on patient safety (internal, health authorities, patients etc.), it is important that we continuously strive to improve our processes, to develop our competencies, and to understand and adapting to regulatory guidelines in order to provide high quality compliant documents. The Job As manager of Safety Medical Writing, you are accountable for the day-to-day management of the department. This includes people management activities such as coaching, motivating, goal-setting, individual competency development, and regular 1:1 feedback meetings. It also includes resource planning and the distribution of workload to medical writers for assigned documents and projects. In this role, you will review and provide constructive input for key documents, ensuring high quality and compliance with applicable regulatory guidelines, internal and industry standards. Deadlines, cross-functional collaboration, and development of your staff will be part of your busy workday. It will be your job to set direction for your team and, whenever necessary, to participate in the implementation of new guidelines and continuous quality improvement projects. As such, you will have a major influence on ensuring NovoNordisk A/S remains compliant with reporting requirements. Reporting to the Director of Safety Surveillance and Global Safety IT, you become part of the local management team, comprising three distinct yet closely interconnected operational areas: Safety Medical Writing, Safety Publishing, and Global Safety IT. Qualifications You have successful experience with people management. You have a university degree (MD, M.Sc. Pharm., M.Sc. Human Biology or equivalent). A scientific degree (e.g. PhD) would be an additional asset. You have a minimum of two years of experience from the pharmaceutical industry (e.g. Regulatory Affairs, R&D or Pharmacovigilance). You have solid experience with medical writing/regulatory writing. As a person you are optimistic, energetic and passionate in relation to your job. You have excellent people skills and your leadership style is characterized by high empathy and the ability to coach and motivate your team to high performances. You have good communication skills and you are a well organised, responsible, independent team player. You have strong planning, and project management skills, along with initiative and ability to be productive with minimal supervision. You are able to prioritise tasks and work under pressure when needed. You are fluent in English, both written and spoken, and you are an experienced user of MS Office (Excel, PowerPoint, Word, Outlook).The application should be written in English. At Novo Nordisk, your skills, dedicat

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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