Job Summary & Responsibilities
The Technical Writer is responsible to provide leadership, direction and training to the project teams regarding planning, preparation and editing of technical documents in support of regulatory submissions. Author technical sections of regulatory documents and work with subject matter experts to provide comprehensive submission packages.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Manage and compile regulatory documents for presentation purposes and ensure consistency of Regulatory documents
Review and edit documents with high quality scientific content, organization, clarity, accuracy, and format with adherence to Regulatory guidelines
Design and implement a company style guide and training program with the aim to improve document preparation processes in support of Regulatory submissions
Work with project team members to improve systems for preparation and review of documents within agreed timelines; Project and program management for IPM pipeline
Be an expert in regulatory guidelines, technological advances and industry standards relating to document preparation; Electronic submission experience
Toxicology, GLP, Study Design, data interpretation; IND/CMC writing experience
Working knowledge of EMA Guidelines and approvals
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
Bachelor degree in a biological scientific field required. MS/MA college degree in biology, life science or related experience preferred
Ideal candidate should have five (5+) years’ experience authoring regulatory submission documents
Knowledge, Skills, and Abilities
Demonstrated experience with Microsoft Office (Outlook, Word, Excel, Access and Power Point) Web-based research and information collection skills
Good command of the English language. Good verbal and written communication skills. Ability to proofread, edit and prepare routine written communication. Ability to respond in a clear and concise manner to requests and questions
Strong organization, planning, and problem-solving skills
Strong self-management skills. Ability to set well-defined and realistic goals; monitor progress and achieve results; manage own time and deal with stress effectively; manage multiple tasks and projects.
Ability to plan work in accordance with general direction.
Strong results orientation, i.e., the ability to work at a fast pace and meet critical deadlines
Attention to detail and accuracy. Thorough when performing work and conscientious about attending to detail.
Commitment to the delivery of excellent customer service; work and communicate with clients and customers to satisfy their expectations. Committed to quality service.
Ability to understand and control confidential information with absolute discretion.
Team player and excellent interpersonal communication skills.
Tolerant of some ambiguity; work well under pressure; assertive; and well organized.
Terms and Conditions
Position located at Headquarters in Silver Spring, Maryland. Job holder should expect fast-paced working environment. IPM is an Equal Employment Opportunity employer.
This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned. IPM has the right to revise this job description at any time. IPM is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and IPM.