Director Scientific/ Medical Writing

Mainz, Germany   |   full time   |   Job ID: 9902 

The 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 until and beyond marketing approval. This includes the completion (hands on) with no supervision/guidance of low to high complexity scientific/medical writing tasks, including those where extensive adaptation of standard procedures and/or new definition of procedures is required. This also includes being the lead medical writer for clinical parts of dossiers for new marketing authorizations BLA/MAA. The position holder has responsibilities as departmental “subject matter expert” for assigned role-relevant topics, e.g., for specific processes such as for R&D support, medical safety support, biomarker support, etc.

Key Responsibilities

With no supervision/guidance:

• Write, edit, and format a wide range of documents (of low to high complexity) required from discovery until and beyond marketing approval.
• Perform (hands on) with no supervision/guidance assigned low to high complexity scientific/medical writing tasks, including those where extensive adaptation of standard procedures and/or new definition of procedures is required. 
• Coordinate the document preparation, review, and approval. 
• Check and revise documents with regard to scientific content, completeness, consistency, and standards compliance.
• Lead and manage teams of writers involved in the preparation of clinical parts of dossiers for new marketing authorizations BLA/MAA.
• Leverage extensive prior strategic experience as medical writer for clinical parts of dossiers for new marketing authorizations BLA/MAA to ensure a successful submissions.
• Leverage extensive prior experience interacting with regulatory authorities to ensure a timely and successful response to authority questions and/or requests.
• Manage outsourced tasks: Plan, support statement of work 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 (i.e., by training and guiding) with international pharmaceutical requirements, including applicable guidelines, regulations, and laws.
• Maintain awareness of updates to applicable guidelines, regulations, and laws.
• Lead (hands-on) the implementation of role-relevant tools, guidelines, SOP documents and templates, instructions, and/or training materials.
• Identify process (organizational, technical and/or process) deficits, rally support, and drive and implement process optimizations in collaboration with relevant internal partners.
• In the absence of suitable standards/processes, create and implement suitable standards and processes ad hoc to meet the team objectives.
• Responsibilities as departmental “subject matter expert” for assigned role-relevant topics, e.g., for specific processes such as processes for R&D support, medical safety support, biomarker support, etc.

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.
• >10 years (hands-on) experience working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology. 
• >10 years (hands-on) experience as a scientific or medical writer in the pharmaceutical /biotech industry. · Prior experience drafting low to high complexity regulatory documents, where extensive adaptation of standard procedures and/or new definition of procedures is required.
• Prior experience drafting alone new or updated CTPs and CSRs required for Phase I-III trials.
• Prior experience drafting high complexity variants of the following (new or updated variants): IBs, clinical CTD-CTA-IMPD/IND modules, clinical CTD-BLA/MAA modules.
• Prior experience as lead medical writer for clinical parts of BLA/MAA dossiers, ideally for BioNTech-relevant indications.
• Prior experience managing small teams of writers supporting the drafting of BLAs/MAAs dossiers.
• Prior experience drafting of the following (new or updated variants): DSURs/Annual Reports, RMPs, RFI 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 high complexity variants of R&D reports.
• 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.
• Advanced motivation, coordination, and conflict resolution skills.
• Expert MS Word skills.
• Good MS PowerPoint & Excel skills.
• Good Adobe Acrobat Pro skills.
• Good MS TEAMs / SharePoint skills.
• Advanced DMS author user skills.
• Advanced 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).
• Advanced knowledge of the drug development process and the needs of relevant stakeholders, ideally also experience in other related roles and/or experience working in multiple companies.
• Advanced knowledge of statistics, trial design, data reporting, and relevant experimental models. · Advanced knowledge of 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.