A Day in the LifeThe Medical Writing Manager is responsible for overseeing and managing the execution of clinical regulatory documents supporting clinical report deliverables, ensuring successful preparation of high quality submission-ready documents and leading effective implementation of the clinical regulatory writing process. The position will initially focus on development of Clinical Evaluation Reports (CERs), with future additional responsibility for development of other clinical documents such as Post-Market Surveillance Reports, Clinical Study Reports, Annual Clinical Trial Progress Reports, etc.
This individual will have demonstrated expertise in partnering with clinical research managers, regulatory affairs managers, quality specialists, and biostatisticians (which may include vendors or consultants) to develop schedules and execute tasks aligned with critical business timelines. This individual will manage a growing team of internal and potentially external medical writers and similar professionals. During function growth, this individual will also contribute as a medical writer.
The successful candidate will have demonstrated the ability to develop solutions to complex problems that require the regular use of ingenuity and creativity and ensure that solutions are consistent with organization objectives. Results are accomplished through managing the clinical report writing process and available resources to ensure compliance with corporate and department policies and strategies, medical writing procedures and guidelines, and people management activities. Must Have: Minimum Qualifications• Master’s Degree in a scientific discipline with 3+ years of experience developing scientific/clinical publications or reports or a Bachelor of Science with 5+ years• Direct experience demonstrating knowledge of medical and/or scientific writing within a medical device or related industry, preferably with writing of Clinical Evaluation Reports. • Project management experience
Nice to Have• PhD or PharmD with 3+ years of relevant experience• 3+ years of people management experience• Strong knowledge of regulatory guidance relative to Clinical Evaluation Reports, and the essential requirements for safety and performance of Medical Devices as defined in Annex I of the Medical Device Directive 93/42/EEC and Annex I of the Active Implantable Medical Device (AIMD) Directive 90/385/EEC,(Annex I Section 6a and Annex X (MDD) / Annex 1 Section 5a and Annex 7 AIMD), the MEDDEV and EN ISO 14155. • Knowledge of clinical research methodology, tools, processes and regulations• Ability to critically analyze and interpret scientific data• Highly proficient in the use of Microsoft Office Suite software, Adobe software, and EndNote Reference software• Adept in performing literature searches in Pubmed and other relevant platforms• Expertise in literature identification and analysis• Understanding of statistical methods• Ability to independently coordinate and prioritize multiple projects simultaneously• Ability to build and foster relationships with key business stakeholders and cross-functional team members• Prefer candidate with experience in medical device, bio-tech and pharmaceutical industry• Medical device development experience• Strong complex project leadership skills and excellent interpersonal communication skills• Highly motivated and capable of comprehending large amounts of scientific content, which is then communicated in a clear, concise fashion.