Associate Director, Medical Writing
- Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with cross-functional team with oversight
- Performs quality checks of documents and data files
- Performs technical edits and formatting of documents, maintains templates, SOPs, Style Guides, and work instructions
- Communicates proactively and efficiently within the MW team and across other functional areas
- Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, study manuals, consent forms, analysis plans, data outputs)
- Coordinates and leads document submission workflows (eg, kick-off meetings, roundtables, reviews, quality control (QC) and other content activities, approvals) by managing issues and facilitating resolutions
- Works with project management to develop timelines for documents and communicates with team members to maintain awareness of expectations, milestones, and deliverables
- Collaborates with cross-functional team to review study results
- Contributes scientific knowledge and analytical skills to the production of documents
- Participates in developing key messages for routine documents and conducts literature searches
- Reviews clinical trial registry postings for assigned studies
- Stays current with respect to key global guidance documents, regulations, or directives
- Works effectively with an electronic document management system and related tools to develop clinical documents
- Maintains effective working relationships with contractors, vendors, and partners
- Experience and knowledge in the preparation of documentation supporting global regulatory submissions. Experience with marketing applications is a plus, but not required
- Experience producing high-quality scientific/medical documents
- Ability to understand, analyze, interpret, and summarize clinical and scientific data
- Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
- Basic project management skills
- Initiative and creativity in solving routine problems for individual documents and identifying process improvements within the Medical Writing department
- Attention to detail related to consistency, grammar, syntax, and scientific accuracy
- Basic computer skills related to word processing, templates, table/figure creation, and literature searches
- Knowledge and understanding of applicable US and global regulations and guidance
- Knowledge of eCTD content/format requirements
- Excellent verbal and written communication skills
- Strong organizational skills
- Strong interpersonal skills and ability to work effectively with a variety of personnel including contract medical writers
- Bachelor's degree
- 5+ years of experience writing clinical regulatory documents
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
Recommended Jobs
Luxury Watchmaker - REEDS Jewelers, Fenton
A New Landmark Store. A Timeless Career Opportunity. At REEDS Jewelers, we believe that every milestone deserves to be celebrated, and every moment honored with meaning. As we approach our 79th an…
Data Scientist I
We are seeking a motivated and detail-oriented Data Scientist to join our dynamic team at First Bank. As part of our growing Data Science, Engineering and Analytics Team, you will have the opportun…
Outreach Coordinator
We're growing fast and looking for a dynamic, outgoing Outreach Coordinator who can help us share our mission with more families and deepen our impact across the community. If you love building relat…
Remote Client Advisor - Entry Level
The Hoffmann Sr. Agency, a partner of Symmetry Financial Group, is looking for driven, motivated, coachable entrepreneurs to join our team and help protect families across the nation with various form…
Breast Radiologist - Earn over 700K!
?Independent group seeking a Breast Radiologist near Charlotte, NC! Growing Private group with Partnership Tracks! Contact: Raymond Stiles(843-574-8233)[email protected] About the Grou…
Specialist Quality Assurance
job summary: The QA will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will c…
Clinical Education Manager
At ScionHealth , we empower our caregivers to do what they do best. We value every voice by caring deeply for every patient and each other. We show courage by running toward the challenge and…
Education Specialist, Corporate Community Health (supplemental)
Overview: The Education Specialist, Corporate Community Health provides work site wellness services to corporate and community client groups. Conducts screenings, administers and processes health ris…
Field Data Collection Driver
We’re seeking a reliable, safety-conscious, and tech-savvy Field Data Collection Driver to support a high-precision mapping initiative for our client’s digital mapping project . In this role, you…