Head of Scientific/Medical Writing

Mainz, Germany | full time | Job ID: 11753

About the Role

The Head of Scientific/Medical Writing has responsibilities as head of a department composed of four groups and operationally as scientific/medical writer (the split is 60%/40%).

As Head of Department:

• For creating and maintaining a cohesive, collaborative, innovative team which understands business needs, is highly flexible, and concentrates on delivering added value.
• For driving company strategies and standards for regulatory documents, maintaining awareness of updates to applicable laws and guidelines, as well as driving the implementation of standards and/or process optimizations in collaboration with relevant internal partners.
• For providing strategic guidance to support the handling of non-standard needs or situations by leveraging prior experience, knowledge of role-relevant regulations/guidance and company standards.

As Scientific/Medical Writer:

• For ensuring the timely generation of a wide range of clinical regulatory documents required for the development of novel therapeutic agents from discovery up until and beyond marketing approval. This includes providing hands-on scientific/medical writing support (drafting, editing, process management) for the preparation of new or updated CTPs, CSRs, IBs, clinical CTD-CTA-IMPD/IND modules, clinical CTD-BLA/MAA modules, response documents, briefing documents, DSURs, PBRERs, etc.
• For providing strategic guidance to support successful BLA/MAA submissions and/or responses to authority questions and/or requests.

Your Contribution:

Responsibilities as Scientific/Medical Writer (40%)

• Perform independently complex scientific/medical writing tasks for low to high complexity documents required for the development of novel therapeutic agents from discovery up until and beyond marketing approval. This may include those where extensive adaptation of standard procedures and/or new definition of procedures is required.
• Perform review of regulatory documents for compliance with BioNTech standards and relevant regulations/guidance on the structure, format and content of regulatory documents, as well as compliance with trial transparency and data privacy requirements.
• Lead teams of writers involved in the preparation of dossiers for marketing approval and life cycle management of approved products.
• Leverage extensive prior strategic experience as medical writer for clinical parts of dossiers for BLA/MAA to ensure successful submissions and/or responses to authority questions and/or requests.

Responsibilities as Department Head (60%)

• Create and maintain a cohesive, collaborative, innovative team which understands business needs, is highly flexible, and concentrates on delivering added value.
• Line manage a team, including. This includes:
• Recruit, supervise, mentor, and develop reports.
• Set up report objectives, provide interim assessments (including identifying and giving feedback on deficits, and advising how to improve), perform annual performance assessments.
• Ensure optimal and fair assignment of tasks to reports.
• Ensure timely completion of assigned training by reports.
• Ensure report compliance with company values, applicable standards, processes/policies.
• Ensure reports have a ‘can do’ attitude, complete tasks on time at quality, while concentrating on delivery and adding value.
• Perform overall department FTE and budget planning.
• Provide strategic guidance to support the handling of non-standard needs or situations by leveraging prior experience, knowledge of role-relevant regulations/guidance and company standards.
• Be accountable for/provide leadership/define company strategies and standards for regulatory documents supporting clinical development and post-approval life cycle management of medicinal products.
• Maintain awareness of updates to applicable guidelines, regulations, and laws for scientific medical/writing topics.
• Identify process (organizational, technical and/or process) deficits, rally support, and drive and implement process optimizations in collaboration with relevant internal partners.
• Lead (hands-on) the implementation of role-relevant tools, guidelines, SOP documents and templates, instructions, and/or training materials.
• Foster knowledge (i.e., by supporting, training, and guiding) and compliance with role-relevant processes, templates, and standards.
• In the absence of suitable standards/processes, create and implement suitable standards and processes ad hoc to meet the team objectives.

A Good Match:

Minimum Qualifications:

• A relevant science/medical university degree, ideally an M.D. or Pharm. D or a Ph.D., ideally with background knowledge (e.g., post-doctoral experience) in immunology and oncology.

Professional experience:

• 15 years (hands-on) experience as a scientific or medical writer in the pharmaceutical/biotech industry drafting low to high complexity regulatory documents for multiple indications, preferably in BioNTech-relevant indications, where extensive adaptation of standard procedures and/or new definition of procedures may be required. Including prior experience:

• Drafting low to high complexity variants of the following or equivalents: CTPs and CSRs for Phase I-III trials, IBs, clinical CTD-CTA-IMPD/IND modules, clinical CTD-BLA/MAA modules.
• As lead medical writer for teams of writers for clinical parts of BLA/MAA dossiers.

• 10 years experience as a line manager, with budget, resource, and project management responsibilities.

• Prior experience with inspections by regulatory authorities.
• Prior experience interacting with relevant industry stakeholders (e.g., EFPIA, ICH), professional bodies (e.g., EMWA), and regulatory authorities (e.g., FDA, Health Canada, EMA).
• Ideally, prior experience in at least two roles in clinical development of novel therapeutic agents.

Additional Skills or Knowledge:

• Leader with vision and a ‘can do’ attitude with the ability to work according to tight timelines and to prioritize workload, while concentrating on delivery and adding value.
• Strong influencing, negotiation, conflict resolution, mediation, and project management skills.
• Advanced people management skills, including the ability to create/maintain a cohesive, collaborative, innovative team which understands business needs and concentrates on delivering added value.
• Advanced knowledge of role-relevant regulations/guidance on the structure, format and content of regulatory documents (e.g., EU CTR, ICH E3, E6, and E9, as well as relevant FDA guidance) and relevant technical specifications (e.g., ICH M4).
• Advanced knowledge of the drug development process and the needs of relevant stakeholders.
• Knowledge of business acumen (planning, operations, finance, and strategy) and budget (FTEs and financial) planning .
• Good knowledge of relevant labor and health/safety at work laws and requirements.
• 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.
• Expert MS Word skills.
• Good MS PowerPoint, Excel, MS TEAMs, DMS (e.g., Veeva Vault) user skills.
• Advanced knowledge of statistics, trial design, data reporting, relevant experimental models, and outcome measures used in trials for immunotherapeutic agents (e.g., RECIST).

Your Benefits:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!