Mainz, Germany | full time | Job ID: 10679
About the Role:
As an Associate Director Scientific/Medical Writing, you will play a pivotal role in advancing BioNTech’s mission to revolutionize medicine by ensuring the timely creation of high-quality scientific and regulatory documents. Your contributions will directly impact the development and approval of novel therapeutic agents, supporting BioNTech's efforts to address diseases with high medical needs. Collaborating within a dynamic and innovative environment, you will work closely with cross-functional teams to maintain excellence in scientific communication.
You will join a workplace that values diversity, creativity, and professional growth while contributing to projects that improve global health outcomes. This role is central to shaping the documentation standards for groundbreaking therapies, allowing you to make a meaningful difference in science and medicine.
Your Contribution:
With limited supervision/guidance: -
* Write, edit, and format a wide range of documents (of low to high complexity) required for research, non-clinical, clinical development, and post-approval life cycle management largely according to standard procedures.
Coordinate the document preparation, review, and approval.
* Check and revise documents with regard to scientific content, completeness, consistency, and standards compliance.
* Manage outsourced tasks: Plan, support SoW set up, coordinate, and manage external writers providing medical writing services.
* Foster knowledge (i.e., by supporting, training, and guiding) and compliance: -
o with relevant processes, templates, and standards.
o with good writing practices and the structure/formatting requirements for scientific documents.
o with international pharmaceutical requirements, including applicable guidelines, regulations, and laws.
* Support the implementation of role-relevant tools, guidelines, SOP documents and templates, instructions, and/or training materials.
* Perform with limited supervision complex medical writing tasks for programs and/or low to high complexity documents, where some adaptation of standard procedures is required.
A Good Match:
* A relevant science/medical university degree, ideally an M.D. or Pharm. D or a Ph.D., ideally with background knowledge in immunology and oncology.
* >5 years (hands-on) experience: -
o working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology.
o as a scientific or medical writer in the pharmaceutical/biotech industry.
* Prior experience: -
o drafting documents for multiple indications, preferably in BioNTech-relevant indications.
o drafting alone new or updated CTPs and CSRs required for Phase I-III trials.
o drafting low to medium complexity variants of the following (new or updated variants): IBs, clinical CTD modules, DSURs/Annual Reports, RMPs, Response documents, Diversity Plans, PIPs/PSPs, and other CTD Module 1 documents.
o editing/reviewing R&D reports.
o drafting (from source data) low to medium complexity variants of R&D reports.
* Native-level written and spoken English, good German skills would be advantageous.
* Ability to interpret and summarize scientific results in a clear, unambiguous, and concise manner.
* Excellent attention to detail.
* A ‘can do’ attitude with the ability to work according to tight timelines and to prioritize workload, while concentrating on delivery and adding value.
* Advanced: -
o interpersonal skills, motivation, coordination, and conflict resolution skills.
o MS Word skills, MS 365 software (TEAMS, SharePoint, PowerPoint & Excel) skills, Adobe Acrobat Pro skills and DMS author user skills.
* Good knowledge of
o relevant regulations / guidance on the structure, format and content of regulatory documents (e.g., ICH E3, E6, E9, as well as FDA guidance on BB, Diversity Plans, master protocols, EU CTR, GDPR), on relevant technical specifications (e.g., ICH M4).
o the drug development process and the needs of relevant stakeholders, ideally experience in other related roles.
o statistics, trial design, data reporting, and outcome measures used in trials for immunotherapeutic agents (e.g., RECIST).
Your Benefits:
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.
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.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.