Senior Regulatory Medical Writer

Role Description

We are excited to expand our Medical Writing FSP Team and are seeking candidates based in the US! As a remote-based Senior Medical Writer within the FSP team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. The Senior Medical Writer may assist the program manager. The successful candidate will have a proven track record in authoring clinical regulatory documents; ideally they will also bring the versatility to author and support preclinical regulatory documents as part of a broader regulatory writing portfolio.

Essential Functions

• Serves as a primary author who writes and provides input on routine clinical documents such as clinical study reports and study protocols and summarizes data from clinical studies.
• Serve as a primary author who writes complex clinical and scientific and program level documents, such as IBs, bioassay reports, INDs, and MAAs.
• Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.
• Ensure documents align with regulatory guidelines, company standards, and industry best practices.
• Provide input on document content, structure, and presentation.
• Review and provide feedback on documents prepared by other team members.
• Manage timelines and deliverables for assigned projects.
• Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
• Stay current with industry trends, guidelines, and regulatory requirements.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Requirements

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills.
• Strong project management skills.
• Excellent interpersonal skills including problem solving.
• Strong negotiation skills.
• Excellent oral and written communication skills with strong presentation skills.
• Significant knowledge of global, regional, national, and other document development guidelines.
• Great judgment and decision-making skills.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.