Associate Director Scientific/Medical Writing

Overview

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 hands-on completion with limited supervision 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.

Responsibilities

• Write, edit, and format a wide range of documents (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 setup, coordinate, and manage external writers providing medical writing services.
• Foster knowledge and compliance with relevant processes, templates, and standards through training and guidance.
• Foster knowledge 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, SOPs, templates, instructions, and training materials.
• Perform complex medical writing tasks for programs and/or low to high complexity documents with some adaptation of standard procedures as needed.

What You Have To Offer

• A relevant science/medical university degree, ideally an M.D. or Pharm.D or Ph.D., with background knowledge in immunology and oncology.
• Greater than 5 years (hands-on) experience in drug development in a therapeutically relevant field, preferably in oncology and/or immunology.
• Greater than 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 new or updated CTPs and CSRs required for Phase I-III trials.
• Prior experience drafting low to medium complexity variants of: 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 are advantageous.
• Ability to interpret and summarize scientific results clearly, unambiguously, and concisely.
• Excellent attention to detail and a can-do attitude with the ability to work under tight timelines and prioritize workload.
• Advanced interpersonal, motivation, coordination, and conflict-resolution skills.
• Advanced MS Word, MS 365 (Teams, SharePoint, PowerPoint, Excel), Adobe Acrobat Pro, and DMS authoring skills.
• Good knowledge of relevant regulations/guidance on regulatory documents (e.g., ICH E3, E6, E9; FDA guidance; EU CTR; GDPR) and technical specifications (e.g., ICH M4).
• Good knowledge of the drug development process and stakeholder needs; experience in related roles is a plus.
• Good knowledge of 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 determined by the role, location, qualifications, and experience. Note: Availability, eligibility, and design of listed benefits may vary by location. Final requirements are based on internal policies and applicable law.

How to apply

Apply now by sending your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, a motivation letter, and your contact details via our online form.

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