Technical Writer

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The Technical Writer for the New Product Introduction (NPI) initiative is responsible for developing, updating and tracking documents for the NPI Work streams. This role will also manage Quality Records. This role requires effective collaboration with the Business Process Owners to deliver on projected timelines. The successful candidate will work effectively within cross-functional teams and also independently to accomplish objectives.

Job Responsibilities:

Work with the NPI Workstream Leads and Business Process Owners to develop, update and consolidate procedural documentation including Work Practices (WP), Standard Operating Procedures (SOP), Job Aids, Work Instructions (WI), Guidance Documents and related documentation for the project.

Works with Business Process Owners to acquire thorough knowledge of the processes for content documentation that is being developed.

Assess available information to determine whether existing controlled documents require revision or new controlled documents need to be created.

From assessment take available information and develop draft of procedural document to be used for process owner and SME review.

Assist in review and routing for approval of current procedural documents to proactively identify key gaps that workstream teams need to remedy during the writing process.

Effectively driving and tracking documents status across the NPI programs.

Responsible for leading review meetings with subject matter experts and Business Process Owners.

Follows the procedural documentation content development project plan to develop new documents, consolidate, and modify content.

Utilizes client templates, styles guide, and follows governance in developing content.

Interfaces with and supports CDE Workstream Leads, Process Business Owners and key stakeholders.

Active participation in team meetings.

Effectively manage projects, escalate issues as necessary and identify/meet key milestones.

Team leadership skills that contribute to meeting team goals and resolving complex issues.

Works independently but able to request guidance/assistance as needed.

Successfully negotiate and influence solutions without direct authority.

Skills/Knowledge Required:

BA/BS degree or equivalent in a relevant scientific discipline as well as medical or computer science background.

1+ year of direct experience in content development, communications and technology documentation in Biotech / Pharma industry.

Excellent writer and editor.

Familiar with and have experience in the Biotech / Pharma industry and the clinical development processes.

Strong communication skills, excellent written, verbal, interpersonal and organizational skills.

Ability to translate complex ideas and information into organized, guided resources to enhance end user experience.

Understanding of content creation best practices (capture, creation and organization of information across multiple channels).

Refined skills of grammar and syntax; ability to adapt writing styles quickly and gracefully; good ear for language and finding the most appropriate and effective way to report.

Ability to stay on schedule under tight, frequently client changed deadlines.

Experience in working directly with key stakeholders, team members, technical experts, and professional staff.

Expert experience with Microsoft products Office including Word, PowerPoint, Excel, Outlook, and SharePoint.

Ability to interpret Microsoft Visio process diagrams.

Ability to work under minimal supervision.

Experience in Content Development including SOPs, WPs, WIs, Guidance Documents, and Job Aids.

Experience in Quality Change Management Record is a plus.

Knowledge of regulatory guidelines to meet pharma compliance requirements in SOPs, a plus.

Demonstrated ability to work in a team environment with team members.

Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations.

BA/BS; 1 plus years…