A Writer writes books, stories, articles, scripts or other original material, including fiction and non-fiction. Works independently or as staff for a magazine, newspaper, journal or social media organization.
Target of 40 hours/week; hours may vary based on workload
Preference:
East Coast candidates preferred Position Summary We are seeking an experienced Senior Medical Writer to provide high-quality regulatory medical and scientific writing support for Phase 1-3 clinical development programs involving pharmaceutical and biologic products. The ideal candidate will bring strong medical writing expertise, therapeutic area knowledge, and a solid understanding of clinical development and global regulatory requirements. This role works closely with internal and external stakeholders to develop high-quality regulatory documents and ensure timely delivery. Key Responsibilities Serve as a primary author for regulatory documents supporting Phase 1-3 clinical development, including clinical study protocols, protocol amendments, and Clinical Study Reports (CSRs) . Research, author, and edit complex clinical, scientific, and regulatory documents, including Investigator's Brochures (IBs), IND documents, and MAA documents . Review documents prepared by junior writers and peers and provide constructive feedback. Mentor and train junior medical writers on document development, regulatory requirements, processes, and therapeutic area knowledge. Ensure documents meet applicable quality standards, regulatory requirements, and client-specific expectations. Develop and implement best practices to improve document quality, efficiency, and delivery. Support program management activities, including timelines, budgets, forecasts, and contract modifications, as needed. Identify and address scope changes and out-of-scope activities. Use appropriate AI and technology-enabled tools to improve the efficiency and quality of document development while following applicable policies and client requirements. Manage multiple priorities in a fast-paced environment while meeting critical client and regulatory submission timelines. Deliver high-quality work within established timelines, budgets, and client expectations. Qualifications Bachelor's degree in a scientific discipline or equivalent relevant education and experience; advanced degree preferred . 5+ years of relevant experience in medical writing or a comparable field. Pharmaceutical or CRO industry experience preferred. Medical writing certifications such as AMWA, EMWA, or RAC are advantageous. Strong understanding of global, regional, and national regulatory and document development guidelines. In-depth knowledge of at least one specialty area, such as clinical development, preclinical research, therapeutic areas, or regulatory submissions. Skills & Competencies Excellent medical writing, editing, proofreading, and data interpretation skills. Strong project management and organizational abilities. Excellent written, verbal, and presentation skills. Strong interpersonal, problem-solving, negotiation, and decision-making skills. Exceptional attention to detail and quality. Ability to work independently while collaborating effectively with cross-functional and external teams. Strong computer skills, including Microsoft Office, Excel, Outlook, client templates, and document management systems. Ability to adapt to changing priorities and work effectively under tight deadlines. Work Schedule This is a fully remote position , Monday through Friday, generally 8:00 AM-5:00 PM . The target schedule is approximately 40 hours per week , although hours may vary depending on workload and business needs. East Coast candidates are preferred.
Pay Details:
$72.90 to $81.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for
Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
