Associate Director Scientific/Medical Writing

Mainz, Germany | full time | Job ID:9674

The Associate Director Scientific/Medical Writing is responsible for ensuring the timely generation of high-quality scientific/regulatory documents required for the development of novel therapeutic agents from discovery up until and beyond marketing approval. This includes completion (hands on) with limited supervision/guidance of low to medium complexity scientific/medical writing tasks, including those where some adaptation of standard procedures and/or new definition of procedures is required. 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 with relevant processes, templates, and standards.
• Foster knowledge (i.e., by supporting, training, and guiding) and compliance with good writing practices and the structure/formatting requirements for scientific documents.
• Foster knowledge and compliance 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 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 working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology.
• >5 years (hands-on) experience as a scientific or medical writer in the pharmaceutical/biotech industry.
• Prior experience drafting documents for multiple indications, preferably in BioNTech-relevant indications.
• Prior experience drafting alone new or updated CTPs and CSRs required for Phase I-III trials.
• Prior experience 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.
• Prior experience editing/reviewing R&D reports.
• Prior experience 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 interpersonal skills, motivation, coordination, and conflict resolution skills.
• Advanced MS Word skills, MS 365 software (TEAMS, SharePoint, PowerPoint & Excel) skills, Adobe Acrobat Pro skills and DMS author user skills.
• Good knowledge of 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).
• Good knowledge of the drug development process and the needs of relevant stakeholders, ideally experience in other related roles.
• Good knowledge of statistics, trial design, data reporting, and outcome measures used in trials for immunotherapeutic agents (e.g., RECIST).

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.