Manager / Senior Manager, Medical Writing 1365724

Location: Remote (CA, NY, NJ, CT, MA, DE)
Therapeutic Area: CNS / Epilepsy

Job Overview:  This role will provide expert medical writing support across preclinical and clinical projects, including data review and analysis, through collaborative work and strong internal relationships.

Responsibilities:

• Develop, write, edit, and format essential clinical development documents, including clinical protocols, Investigators Brochures, clinical study reports, informed consent forms, safety and efficacy summaries, and briefing documents.
• Ensure adherence to timelines and streamline the workflow of writing assignments for timely completion.
• Oversee the review and finalization of internally produced documents and those from contractors/vendors, serving as a subject matter expert and representing Medical Writing on project teams.

Qualifications:

• Hold a Bachelors, Masters, or PhD degree in a scientific, medical, or clinical discipline.
• Possess 5-10 years of experience in the pharmaceutical/biopharmaceutical industry or at a clinical contract research organization (CRO), with a preference for experience in neurosciences.
• Demonstrate 5-10 years of industry regulatory writing and clinical medical writing experience, including expertise in regulatory submissions to Health Authorities.

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.

EEO Employer

Apex 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. 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 our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.