Manager Scientific/Medical Writing (16-month contract) (Mainz, RP, DE, 55116)

Mainz, Germany   |   full time   |   Job ID: 11674

About the role:

The position holder 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 some supervision/guidance of low to medium complexity scientific/medical writing tasks according to standard procedures.

Your contribution:

With supervision/guidance:

Write, edit, and format a wide range of documents (of low to medium 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.

Foster knowledge (i.e., by supporting, training, and guiding) and compliance with relevant processes, templates, and standards.

Perform with limited supervision complex medical writing tasks for low to medium complexity documents.

A good match:

Minimum Qualification:

A relevant life science university degree, ideally an M.D. or Pharm. D or a Ph.D., ideally with background knowledge in immunology and oncology.

Professional Experience:

>3 years (hands-on) experience working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology.

>3 years (hands-on) experience as a scientific or medical writer in the pharmaceutical/biotech industry.

Prior experience drafting documents in BioNTech-relevant indications.

Prior experience supporting drafting new or updated CTPs or CSRs required for Phase I-II trials.

Prior experience drafting low complexity variants of the following (new or updated variants): IBs, clinical CTD-CTA-IMPD/IND modules.

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.

Additional Skills/Knowledge:

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.

Good interpersonal skills.

Good motivation, coordination, and conflict resolution skills

Good MS Word skills.

Good MS PowerPoint & Excel skills.

Good Adobe Acrobat Pro skills.

Good MS TEAMs / SharePoint skills.

Good 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).

Knowledge of the drug development process and the needs of relevant stakeholders, ideally experience in other related roles.

Knowledge of statistics, trial design, data reporting, and relevant experimental models.

Knowledge of outcome measures used in trials for immunotherapeutic agents (e.g., RECIST).

Knowledge of good publication practices (GPP3).

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.

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