Senior Medical Writer
Job#: 2042859
Job Description:
Department: Regulatory Affairs & Product Development
Job Description: Regulatory Affairs & Product Development is responsible for nonclinical development consulting to provide innovative solutions and regulatory submissions for all aspects of pharmaceutical, biologics, and device development from discovery through post-approval maintenance.
Key Responsibilities:
- Utilize broad and deep knowledge to develop innovative new business practices, policies, and procedures.
- Contribute to the development of department strategy.
- Work on or lead highly complex projects of large scope, typically cross-functional with significant and long-term impact.
- Provide solutions that set precedents.
- Negotiate complex or risky technical business issues on behalf of the company.
- Independently define projects, establish budgets, identify participants, and mitigate risks.
- Consult with management to determine project objectives with long-term implications.
- Act as a mentor to less experienced colleagues.
Required Skills and Experience:
- 12+ years of experience, preferred.
- Ability to work independently.
- Strong knowledge of regulations and guidelines.
- Scientific and technical reading, writing, and editing skills.
- Well-developed organizational, interpersonal, and communication skills.
- Ability to develop and present varied and unique ideas.
- Proficiency in MS Word, Adobe Acrobat, Project, PowerPoint, and one or more electronic document management systems.
Education:
- Bachelor’s degree in a related field, or equivalent work experience.
Languages:
- English (Speak, Read, Write)
Schedule:
- Hours Per Week: 40
- Hours Per Day: 8
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 [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.