Medical Writing Manager - Munich

작업 내용

• Lead the Global Medical Writing team to ensure appropriate allocation of work across writers
• Direct manager of the MW function, provides leadership, guidance, and mentorship to a team of medical writers. Set clear objectives, goals, and priorities for the team and individuals. Provide regular feedback to team members
• Assess efficiencies, help identify areas for improvement, and initiate improvement processes in alignment with corporate goals/needs
• Oversee the creation of various medical writing content by the team
• Be available to coordinate, author, and edit documents (on an as-needed basis)
• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects/MWs
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects
• Maintain document prototypes and shells, and proactively supported developing and reviewing standard processes and templates
• Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents
• Stay updated on regulatory guidelines and industry best practices to ensure compliance in all medical writing activities
• Review documents as required
• Work effectively and lead in cross-functional working groups
  

• Candidates must have a BS, MS, or science degree (e.g., RN, NP, MSN, PharmD, PhD, MD)
• 10+ years of oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry
• Prior experience leading a diverse Medical Writing team
• Familiarity with the oncology therapeutic area
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA)
• Proficiency in using computer software (e.g., word processing, graphics, reference manager, EndNote, document management systems)
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures, clinical study data collection, and results reporting and post-marketing obligations
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology TA), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory requirements, and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports)
• Ability to interpret and summarize complex tabular and graphical data presentations
• Strong organization, documentation, and communication skills with an ability to multitask
  

• Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
• An open working atmosphere in an international corporate culture with short communication channels
• Comprehensive onboarding program
• Flexible working hours with home office options
• Attractive special payments
• Employee participation program
• Job bike or subsidized job ticket
• Above-average contribution to the company pension scheme
• Individually tailored further training program (including German and English courses)
• Health promotion programs (e.g., subsidy for local fitness studios, sponsorship of sporting events, various lifestyle coaching sessions)