Senior / Manager Medical Writing 1249186\ \ Job Scope & Purpose:\ \ Our long-term client is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy and seeks a talented Senior/Manager Medical Writing. Reporting to the Director, Medical Writing, the Manager/Senior Manager, Medical Writing works flexibly across a number of preclinical and clinical stage projects, providing medical writing expertise, including data review and analysis activities. The role is hands on, requires frequent collaboration and excellent working relationships with various internal groups.\ \ Primary Job Responsibilities:\ \ \ \ Plans, writes, edits, and formats essential clinical development documents, including but not limited to: clinical protocols, Investigator's Brochures, clinical study reports, informed consent forms, integrated safety and efficacy summaries, and briefing documents.\ \ Maintains timelines and workflow of writing assignments and ensures timely completion.\ \ Manages efficient review and finalization of documents produced internally and/or externally contractors and vendors.\ \ Represents Medical Writing on multiple project teams and serves as subject matter expert for clinical development documents.\ \ Works collaboratively within a team environment and interacts directly and independently with all relevant groups.\ \ Develops and updates relevant standard operating procedures as required.\ \ Acts in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.\ \ \ Primary Job Requirements:\ \ \ \ A Bachelor's, Master's, or PhD in a scientific, medical, or clinical discipline.\ \ 5-10 years of previous experience in the pharmaceutical/biopharmaceutical industry or at a clinical contract research organization (CRO), preferably in neurosciences.\ \ 5-10 years of industry regulatory writing and clinical medical writing experience.\ \ A thorough understanding of all phases of the drug development process and the interdependencies between Clinical Development and other functional areas (e.g., CMC, Nonclinical/Toxicology, Regulatory Affairs, etc.).\ \ Extensive experience in regulatory submissions presented to Health Authorities (e.g., clinical protocols, Investigator's Brochures, clinical study reports).\ \ Strong understanding of clinical data and exceptional writing skills.\ \ Proven organizational skills and the ability to work across a variety of teams and manage multiple competing priorities.\ \ Expert in Microsoft Word, Excel, PowerPoint, and related word processing and electronic publishing tools.\ \ Experience with EndNote and StartingPoint templates desired.\ \ Comprehensive knowledge and understanding of ICH-Google Cloud Platform and US, Canadian, and EU regulatory environments; previous experience with CTA, IND, and NDA submissions preferred.\ \ Excellent oral and written communication skills.\ \ Good interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.\ \ Ability to travel on occasion.\ \ \ About Stratacuity:\ \ Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.\ \ PROVEN SCIENTIFIC PLACEMENT™\ \ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.\ \ \ \ Code: ClinOps\ \ \ \ \ \ \ \ \ \ \ \ EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. 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