Clinical Project Manager (Medical Writer)

Position Title: Clinical Project Manager

Function: Pharma Development Regulatory

Department: Documentation

Location: Welwyn

Duration: Full Time
 

As a part of the Clinical Project team you will lead medical writing and editing projects for Late Stage Clinical Development organizations, partnering closely with key stakeholders: Clinical Science Leaders (CSLs), Medical Directors, Clinical Scientists, and protocol authoring teams.


Functions/Responsibilities:
·         Oversees the development of protocols, including drafting, editing, coordination of review, adjudication of review comments, and creation of project timelines.
·         Acts as a key strategic thinking partner for the clinical scientist and other team members on protocol development and the above deliverables.
·         Is a key strategic participant in project teams and committees.
·         Acquires and demonstrates a deep understanding of needs for the clinical science organization.
 
 
Experience
·         Strong medical writing and clinical project management experience, preferably in the biotech/Pharmaceutical industry
·         Superb written and oral communication skills, with a proven ability to communicate effectively with all levels in the organization.
·         Have experience in protocols and Informed Consent Form (ICF) amendments
·         Demonstrated experience in clinical and nonclinical document preparation and finalization.
·         Strong project management and team facilitation skills.
·         Demonstrated ability to collaborate and negotiate business solutions in a complex and fast-paced matrix environment.
·         Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
·         Strong analytical and problem solving skills, paired with strong partnering and performance consulting skills.
·         Ability to work independently and as part of a team.
·         Strong planning and organizational skills, including ability to prioritize and organize high volume workflow and follow a project through to completion, ensuring attention to detail, and highest level of accuracy within required timeframe.
·         High degree of customer focused sensitivity towards both internal and external customers and business partners.
·         Position may require approximately 5% international travel. 
 
·         Bachelor's degree in the biological sciences or liberal arts preferred 

 

• All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.