Director* Scientific/Medical Writing

Open for hire at one of the following locations –  Mainz Goldgrube. - Job ID: 7448 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Director* Scientific/Medical Writing 

Your main responsibilities are:

• Create and maintain a cohesive, collaborative, innovative team of scientific/medical writers responsible for the preparation a wide range of scientific or regulatory documents required for clinical development and post-approval life cycle management.
• Act as role model when independently performing scientific/medical writer tasks for low to high complexity documents, including for marketing approval modules, for novel oncology and infectious disease therapies   

This includes:

• Independently perform scientific/medical writer tasks for low to high complexity documents, including:
  • Coordinate document preparation, review, and approval
  • Write, edit, and/or format a wide range of documents of required for clinical development and post-approval life cycle management. This includes regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, eCTD written/tabular summary and clinical overviews, briefing book, response documents)
  • In the absence of suitable standards/processes, create and implement suitable standards and process ad hoc to meet the team objectives  - Coordinate and manage teams of writers and subject matter experts involved in the preparation of dossiers for marketing approval and life cycle management of approved products
  • Leverage extensive (ideally >8 years) hands-on prior experience interacting with regulatory authorities to ensure a timely and successful response to authority questions and/or requests
  • Leverage extensive (ideally >8 years) hands-on prior experience interacting with regulatory authorities to ensure the optimal presentation of complex information such that BioNTech dossiers for its novel medicines are persuasive and convincing
• Provide expertise and leadership for the development and implementation of role-relevant tools, guidelines, SOPs, and templates
• Provide leadership/help define company strategies and standards for regulatory documents supporting the clinical development, marketing approval, and post-approval life cycle management
• Create and maintain a cohesive, collaborative, innovative team which understands business needs, is flexible, and concentrates on delivering added value. This includes line management of a team (n= <6) of Scientific/Medical Writers, including recruit, supervise, mentor, and develop team members
• Support, train, and guide relevant interacting subject matter experts on good writing practices and the structure/formatting requirements for scientific/regulatory documents

What you have to offer:

• A relevant life science university degree, ideally M.D. or Pharm. D or a Ph.D., ideally with background knowledge in immunology and oncology 
• >8 years (hands-on) experience working in drug development in a therapeutically relevant field, preferably in oncology, immunology, or vaccines
• >8 years (hands-on) experience as scientific or medical writer in the pharmaceutical/biotech industry or vendor setting
• Native level written and spoken English; good German skills would be advantageous.
• A ‘can do’ attitude with the ability to work according to tight timelines and to prioritize workload, whilst concentrating on delivery and adding value
• Proven ability to communicate complex scientific and/or medical data in a concise and explicit, but readily comprehensible manner
• Excellent attention to detail
• Expert user of MS Office applications (Word, PowerPoint, Excel) and Adobe Acrobat Pro
• Prior experience creating and maintain a cohesive, collaborative, innovative team (applicants wishing to develop into a leadership will be considered)
• Advanced interpersonal skills
• Advanced motivation, coordination, and conflict resolution skills
• Advanced knowledge of relevant regulations / guidance on the structure, format, and content of regulatory documents (e.g., ICH E3, E6, E9), on relevant technical specifications (e.g., ICH M4)
• Advanced knowledge of the drug development process, relevant regulations, and the needs of relevant stakeholders
• Advanced knowledge of statistics, study design, data reporting, and relevant experimental models

*Please attach a cover letter to the application.

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz Goldgrube. Apply now for your preferred job and location through our careers site.

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!