Director Of Medical Writing

vor 3 Wochen

Mainz, Deutschland AL Solutions Vollzeit

We are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing. As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regulatory documents.

Key responsibilities include:

  • Managing and mentoring a team of medical writers
  • Providing guidance and expertise on the development of various documents including clinical study protocols, clinical study reports, investigator's brochures, and regulatory submissions
  • Ensuring compliance with relevant regulations and guidelines
  • Collaborating with cross-functional teams including regulatory affairs, clinical operations, and biostatistics
  • Overseeing the review, organization, and interpretation of clinical trial data
  • Contributing to the development of templates, processes, and standard operating procedures

The ideal candidate will have a strong background in medical writing, with a focus on regulatory documents, and proven experience in managing a team.

Requirements

Requirements:

  • Advanced degree in life sciences or related field (PhD, MD, or equivalent)
  • Minimum of 10 years of experience in medical writing, with a focus on regulatory documents
  • Experience in managing a team of medical writers
  • Strong knowledge of regulatory guidelines (ICH, FDA, EMA)
  • Excellent writing and editing skills with attention to detail
  • Proficiency in using relevant software and tools (MS Office, Adobe Acrobat)
  • Ability to effectively communicate and collaborate with cross-functional teams
  • Strong organizational and leadership skills

If you are a highly motivated and experienced medical writer looking for a challenging leadership role, we encourage you to apply.

Benefits

- competitive salary.

- Hybrid working.

- Annual salary reviews.

- Medical insurance.


  • Director Of Medical Writing

    vor 4 Stunden

    Mainz, Deutschland AL Solutions Vollzeit

    DescriptionWe are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing. As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regulatory documents.Key responsibilities include:Managing and mentoring a...

  • Director Of Medical Writing

    vor 1 Woche

    Mainz, Deutschland AL Solutions Vollzeit

    DescriptionWe are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing. As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regulatory documents.Key responsibilities include:Managing and mentoring a...

  • Director Of Medical Writing

    vor 3 Wochen

    Mainz, Deutschland AL Solutions Vollzeit

    DescriptionWe are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing. As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regulatory documents.Key responsibilities include:Managing and mentoring a...

  • Director of Clinical Operations

    vor 1 Tag

    Mainz, Deutschland Proclinical Vollzeit

    Proclinical are recruiting for a Director of Clinical Operations to join a biotech organisation. This role is on a permanent basis and is located in Germany. **Responsibilities**: - Monitor actions connected to the heading of the project teams, the oversight/control of third-party providers, the performance of all services in a timely manner as well as...

  • Director Medical Affairs

    vor 3 Wochen

    Mainz, Deutschland 11 Dexcom Deutschland GmbH Vollzeit

    Director Medical Affairs - DACH (m/w/d) page is loaded Director Medical Affairs - DACH (m/w/d) Apply remote type Flex locations Mainz, Germany time type Full time posted on Posted 9 Days Ago job requisition id JR105714 Über Dexcom Dexcom, Inc. (NASDAQ: DXCM) wurde 1999 gegründet und entwickelt und vermarktet Systeme zur kontinuierlichen...

  • Director Medical Affairs

    Vor 6 Tagen

    Mainz, Deutschland Dexcom Vollzeit

    Über Dexcom Dexcom, Inc. (NASDAQ: DXCM) wurde 1999 gegründet und entwickelt und vermarktet Systeme zur kontinuierlichen Glukoseüberwachung (CGM) für den ambulanten Einsatz durch Menschen mit Diabetes und durch Gesundheitsdienstleister zur Behandlung von Menschen mit Diabetes. Das Unternehmen ist führend bei der Umgestaltung der Diabetesversorgung und...

  • Director of Global Regulatory Affairs

    vor 1 Woche

    Mainz, Deutschland Hobson Prior Vollzeit

    **Salary**: €120000 - €130000 per annum**Job type**: Permanent **Location**: Mainz, Germany **Function**: Regulatory Affairs, CMC **Posted**:14/03/2024 **Ref**: BBBH24877 - Hi I'm Henry , I manage this role Hobson Prior are partnering with a brilliant biotech organisation who are currently looking for an individual to join their team on a...

  • Director Global Regulatory CMC Authoring

    vor 2 Monaten

    Mainz, Rheinland-Pfalz, Deutschland Proclinical Vollzeit

    Proclinical are recruiting for a Director Global Regulatory CMC Authoring to join a biotech organisation. This role is on a permanent basis and is located in Mainz.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance. Responsibilities:Write international quality regulatory documentation for various...

  • Director Medical Affairs

    vor 3 Wochen

    Mainz, Deutschland Dexcom Vollzeit

    Über Dexcom Dexcom, Inc. (NASDAQ: DXCM) wurde gegründet und entwickelt und vermarktet Systeme zur kontinuierlichen Glukoseüberwachung (CGM) für den ambulanten Einsatz durch Menschen mit Diabetes und durch Gesundheitsdienstleister zur Behandlung von Menschen mit Diabetes. Das Unternehmen ist führend bei der Umgestaltung der Diabetesversorgung und...

  • Director Medical Affairs

    vor 1 Woche

    Mainz, Deutschland Dexcom Vollzeit

    Über Dexcom Dexcom, Inc. (NASDAQ: DXCM) wurde gegründet und entwickelt und vermarktet Systeme zur kontinuierlichen Glukoseüberwachung (CGM) für den ambulanten Einsatz durch Menschen mit Diabetes und durch Gesundheitsdienstleister zur Behandlung von Menschen mit Diabetes. Das Unternehmen ist führend bei der Umgestaltung der Diabetesversorgung und...

  • Director Global Regulatory Cmc Authoring

    Vor 7 Tagen

    Mainz, Deutschland ProClinical Vollzeit

    **Salary**: Highly Competitive Job type: PermanentDiscipline: CMC**Location**: Germany- Mainz, Germany - Posting date: 13 Mar 2024 Reference: 59430 Proclinical are recruiting for a Director Global Regulatory CMC Authoring to join a biotech organisation. This role is on a permanent basis and is located in Mainz. Please ensure that you are eligible for...

  • Director, Operational QA Network Management

    vor 2 Monaten

    Mainz, Deutschland Proclinical Vollzeit

    Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis. The opening position currently available is for a Director, operational QA Network Management. **Responsibilities**: - You will lead by example and be a proactive and visible Quality Leader. - Communicate and...

  • Associate Director, Product Quality

    Vor 7 Tagen

    Mainz, Deutschland ProClinical Vollzeit

    **Salary**: €110000 - €120000 per annum Job type: PermanentDiscipline: Good Manufacturing Practice (GMP)**Location**: Germany- Mainz, Germany - Posting date: 01 Feb 2024 Reference: 58714 Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to...

  • Senior Director Biomarker Operations

    vor 2 Monaten

    Mainz, Deutschland Proclinical Vollzeit

    Proclinical are collaborating with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis and is located in Germany. The opening position that is currently available in this organisation is for a Senior Director whose main focus will be on Biomarker Operations. **Responsibilities**: - You will...

  • Director of Gm&e Sales

    vor 2 Monaten

    Mainz, Deutschland Hilton Vollzeit

    Director of GM&E Sales (m/w/d) A GM&E Sales Manager manages the hotel sales in GM&E by recommending growth efforts, monitoring progress, and ensuring that the hotel is competitively positioned within the local marketplace. **What will I be doing?** As Director of GM&E Sales, you are responsible for working closely with the Senior Management Team to drive...

  • Director of Human Resources

    vor 2 Wochen

    Mainz, Deutschland Central Europe Shared Services Center - Mainz Vollzeit

    Summary We _embrace_ Everyone. **Hyatt Services GmbH** are looking for a **Director of Human Resources (f/d/m) **for our office **in Mainz**, Germany. **Our Purpose**:We care for people so they can be their best. **Our Vision**:A world of understanding and care. **Our Mission**:To deliver distinctive experiences for our guests. **Our Values**:Respect,...

  • University Professor

    Vor 4 Tagen

    Mainz, Deutschland Springer Nature Vollzeit

    **University Professor (M/F/d) of Medical Biostatistics**: - Employer- University of Mainz- Location- Mainz-Bingen, Rheinland-Pfalz (DE)- Salary- Competitive- Closing date- 20 Apr 2024- Discipline Biomedicine Job Type Professor Employment - Hours Full time Duration Permanent Qualification PhD Sector Academia- You need to sign in or create an...

  • Director Artist Residency Schloss Balmoral

    vor 3 Wochen

    Mainz, Deutschland Johannes Gutenberg-Universität Mainz Vollzeit

    The Academy of Fine Arts Mainz, at the Johannes Gutenberg University Mainz (JGU), is the only art acade-my in the state of Rhineland-Palatinate. The international Artist Residency Schloss Balmoral came under the auspices of the Academy of Fine Arts in 2021. Together they now form a unique partnership in Germa-ny, facilitating a dialogue between art...

  • Director of Communications Eastern

    vor 2 Monaten

    Mainz, Deutschland EAME Regional Office Vollzeit

    Summary The Director of Communications Eastern & Central Europe is responsible for the Communications strategy across Eastern & Central Europe with the overall goal to support Hyatt’s hotel portfolio, (both operating and opening hotels), drive brand preference and protect brand reputation for Hyatt and its sub-brands in the assigned region. Reporting to...

  • Director of Human Resources

    vor 2 Monaten

    Mainz, Deutschland Hyatt Corporation Vollzeit

    Director of Human Resources (f/d/m) Shared Service Center - Mainz DE - RP - MainzHuman ResourcesDirectorFull-timeReq ID: MAI000638 Summary WE CARE FOR PEOPLE SO THEY CAN BE THEIR BEST. At Hyatt Services GmbH, diversity is not just a buzzword; it's the cornerstone of our success. With a team of over 200 employees hailing from an impressive 52...