Associate Director, Medical Writing

Employer
CSL Behring
Location
Cambridge, Massachusetts
Posted
Jul 16, 2021
Ref
R-135115
Required Education
Bachelors Degree
Position Type
Contract

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Associate Director of Medical Writing is responsible for leadership, co-ordination and risk-management of complex medical writing projects that involve multiple interdisciplinary teams. 

These complex projects deliver high quality documents on time to support the conduct of clinical studies (CSRs, protocols and IBs) and submission dossiers (eCTD).  These projects are mid-term running over multiple seasons.  The Associate Director Medical Writer is responsible for development and implementation of processes, including SOPs, templates.

Responsible for leadership and delivery of complex medical writing projects

  • Contribute to the clinical project team and create an aligned strategy to deliver the clinical documents to accomplish the clinical project goals and wider goals for Seqirus.
  • Anticipate risks and provide mitigation. Proactively prevent or resolve issues related to medical writing deliverables.
  • Coordinate and implement the medical writing project strategy and deliver documents that are of high-quality, on-time and with reasonable expenditure of budget or internal resource.
  • Engage with other members of the Study Execution Teams and Regulatory Strategy Teams to solicit feedback, understand the functional interdependencies and respond to challenges with planned actions that support the team within ClinDev, R&D and the wider Seqirus organization.
  • Assess the consequences and benefits of project team decisions with respect to their impact on Medical Writing processes and deliverables and any functions dependent upon those.  Engage with stakeholders to ensure that this assessment is understood.
  • Ensure in-house / external resource is available to provide medical writing deliverables as required by project team and in line with company objectives.

Manages development of medical-writing related Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables. 

  • Responsible for the creation and implementation of document templates and associated guidance tools (eg, formatting, style and program-specific guides),  to allow teams to author quality documents that meet appropriate corporate, industry, regulatory (FDA, EMEA) and international (GPP) guidelines and requirements.

    Elicit input from global stakeholders (eg, CD, Regulatory, Project Management, Commercial).  Create templates; lead cross-functional, global stakeholder review teams; facilitate issue resolution; obtain approval of templates.

    Facilitate implementation, adherence to and maintenance of guidelines, standards and templates through interactions with key stakeholders (eg, Shared Services).

    Proactively determine the needed changes to existing or creation of new guideline, standards and templates.

    Provide cross-functional training and support with respect to implementation of medical writing best-practices, templates and SOPs.

Manage input into the strategy for medical writing vendor selection, define the scope of work to be outsourced and direct/manage medical writing vendors.

  • Develop and maintain specific medical writing vendor relationships where required.

    Identify potential vendors through contacts and network

    Participant in bid defence, contract development, work alignment and / or operation meetings.

    Negotiate with partner to determine roles, responsibilities, processes and mutual expectations

Responsible for mentorship and supervision of medical writing colleagues

  • Review and provide constructive criticism of documents created by medical writing colleagues.

    Support medical writing colleagues with on the job training.

    Encourage medical writing colleagues to expand and develop their skills.

Education Requirements

An undergraduate degree in pharmacy, biological sciences or related disciplines is essential

Post-graduate qualifications desired (PhD or MD preferred)

Experience Requirements

Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry

As a guide, a minimum of 8 years Clinical experience in the role of medical writer

Excellent level of English language proficiency 

Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and template