This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Job Summary:
The Technical Writer for the Clinical Data EcoSystem (CDE) initiative is responsible for developing and updating Procedural Documents for the CDE Workstreams based on new and integrated processes. 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 CDE 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 of current procedural documents to proactively identify key gaps that workstream teams need to remedy during the writing process.
• Responsible for leading review meetings with subject matter experts and Business Process Owners.
• Work with the Business Process Owners to assess the consolidation effort between the hCelgene and hBMS procedural documents.
• 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.
• Executes content development, review and approval process to meet project deadlines by interfacing with Workstream Leads, Business Process Owners, and other key stakeholders to gain approval for 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.
• 5+ years of direct experience in content development, communications and technology documentation in Pharma industry.
• Excellent writer and editor.
• Familiar with and have experience in the 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 say something.
• 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.
• 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; 5 plus years Pharmaceutical experience, content development and clinical development processes.