Job Description/Major Responsibilities:
Designs, creates, revises and maintains technical documentation. Utilize SME's, design specifications, users, system manuals etc. for guidance.
Interviews subject matter experts and the users of the processes as well as conduct research and have the ability to gather information to produce a clear concise document to the target audience
Form a clear understanding of the purpose of the document that needs to be created.
Gather information from existing process flow documents, equipment manuals and from subject matter experts.
Draft SOPs and explain in simple language scientific and technical ideas that are difficult for the average reader to understand.
Write the SOP in a concise, step-by-step, easy to read and follow format.
Edit, proofread, perform formatting of technical documents for business and consumers.
The information presented in an SOP should be unambiguous and not complicated.
Information should be conveyed clearly and explicitly to remove any doubt as to what is required.
Determine if a Supplement/Form or Work Instruction document is needed. WI contains much more detail than an SOP and is only created if very detailed instructions are needed.
Afterward, develop work Instructions that contains detailed instructions that specify exactly what steps to follow in order to complete an activity.
Communicate activities and results to the site leadership.
Work closely with External Manufacturing Quality to develop and report appropriate metrics.
Autonomy and Complexity:
Demonstrate professional leadership with the proven ability to build business relationships
Strong interpersonal and communication skills are also required as the individual must be able to work both with a team of SME & future user and other authors to move process forward to completion. Demonstrated ability to facilitate groups.
Proactively identifies issues and seeks resolution within the team.
Responsible to provide feedback to upper management.
Education :
Bachelor's degree in either a scientific, engineering field or in English is required; an advanced degree is preferred.
Experience/Technical Competencies:
Comprehensive understanding of the technical writing process.
Proven strong writing and editing skills.
A minimum of 5 years of demonstrated experience in writing SOPs, Supplements/Forms and WIs, in the Pharmaceutical Industry.
Proven track record of strong communication skills demonstrated by successfully communicating with large groups are required.
Job Knowledge/Skillsets:
Ability to communicate effectively to all levels of the organization
Ability to effectively present information and respond to questions or complex inquiries from groups of employees, managers and internal customers
Demonstrated planning and tracking skills
Demonstrated organizational skills, capable of managing multiple tasks
Must have demonstrated strong cross-functional collaboration and teaming in a global environment.
Proven influence, leadership and facilitation skills.
Able to manage time with respect to priorities;
High level of proficiency in Microsoft Office (Visio, Access, Word, Excel, Adobe Acrobat, etc) is required.
Ability to communicate well with all levels of staff and organize inter-departmental meetings is required.
The ability to pay attention to details and accuracy while being flexible, able to adapt to changing priorities
Travel:
<10% travel is anticipated for this role.
Tunnell Consulting - 9 months ago
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