Senior Principal Medical Writer

BeiGene

1d•$137,100 - $182,100•Onsite

About The Position

This position is responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions, and other types of clinical and regulatory documents within the working scope of global medical writing. This position is also responsible for mentoring MWs (full-time employees and/or contractors/vendors) as needed.

Requirements

BS with a minimum of 7 years of regulatory document writing (or equivalent) experience, Masters with 5+ or PhD/PharmD/MD with a minimum of 3+ years of regulatory document writing (or equivalent) experience.
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.

Nice To Haves

An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.

Responsibilities

Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
Be able to manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration).
Proactively leads direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s), and be able to guide other MWs.
Leads part of the creation of document writing template/guidance for all document types within the working scope.
Leads the maintenance of document writing template/guidance for all document types within the working scope.
Navigates through uncertainties to develop and manage timeline of individual documents and multiple documents (supported by different MWs in one project, eg, works as the MW filing lead for an NDA/BLA/MAA submission), including those for complex projects.
Be able to guide other MWs.
Proactively identifies the questions/issues/potential risks that require departmental discussion or team discussion.
Proactively identifies the potential risks and makes a mitigation plan.
Resolves problems efficiently and skillfully.
Be able to guide other MWs in these areas.
Builds strong and in-depth relationship with study team(s) and program team(s) (eg, works as the MW program lead).
Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes.
Be able to guide other MWs and provide suggestions.
Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.
Leads departmental process/tool optimization.
Leads (part of) departmental process/tool establishment.
Leads part of cross-functional process/tool optimization.
Contributes to cross-function process/tool establishment.
Contributes to cross-company process/tool optimization.
Leads (part of) the development of new training programs.
Provides instructions/trainings (content‑wise/process-wise) to other MWs.
Provides systematic technical and operational mentorship to MWs (full-time employees and/or contractors/vendors).
Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes.
Provides topic sharing on regulatory writing and related knowledge within the department and to cross‑functional stakeholders.
Provides topic sharing on regulatory writing and related knowledge across companies (eg, meetings of DIA and medical writing communities).