Associate Medical writer

1 month ago

SAS Nagar Mohali, India Parexel Full time

Job Purpose: With appropriate departmental supervision, the Associate Medical Writer will prepare clinical documents of low complexity and may provide writing support for more complex clinical documentation. Under departmental supervision, the Associate Medical Writer will provide technical and administrative support during preparation of more complex clinical documents.

Key Accountabilities:

Accountability & Supporting Activities

Author Clinical Documents

Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize low complexity documents, such as patient narratives, public disclosure documents, and simple aggregate safety reports (e.g., Periodic Adverse Drug Experience Report [PADERs]), under supervision of the project Lead Medical Writer or other appropriate departmental supervision.With appropriate departmental supervision and mentoring, provide writing support for more complex clinical documents, such as informed consent forms (ICFs) and clinical study reports (CSRs)/CSR shells. This could involve writing certain sections or supporting the Lead Medical Writer on specific authoring tasks. Provide direction to Document Specialists for appendices compilation and related tasks, as required.Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.Ensure that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document.Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.

Quality Control

Under appropriate departmental supervision, perform edits and format changes on documents, as requested.Assist with final quality control check, compilation, formatting, tabulation, and pagination of documents.

Document Project Management

Coordinate production and distribution of draft and final documents to project team and/or client.Schedule and/or attend internal technical team meetings as required.Archive project materials according to Medical Writing Services guidelines and/or provide guidance to Medical Writing Support Coordinators to file project materials per SOP.

Training/ Compliance

Attend and complete mandatory, corporate, project-specific, and departmental training as required.Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department.Assist in the training/mentoring of new departmental staff as required.

General

Attend departmental and company meetings as necessary.Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform.Provide administrative support if requested.

Skills:

Excellent interpersonal, verbal and written communication skills.Ability to consistently produce documents of high quality.Demonstrates attention to details and proactivity.Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths.A flexible attitude with respect to work assignments and new learning; readily adapts to changes.Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members.Strives to understand and satisfy client needs.

Knowledge and Experience:

Exhibits knowledge of regulatory documents and ICH-GCP guidelines.Scientific background essential; some experience of pharmaceutical industry and an understanding of clinical research are preferred.Knowledge or ability to learn software and systems: MS Office (Word proficiency required), document management systems, collaborative authoring (e.g., SharePoint), file conversion and databases (Excel).Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.

Education:

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

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