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Medical Writing Manager

3 months ago

Durham, United States FHI Clinical Inc Full time
Job DescriptionJob Description

Summary of The Position:

The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing Manager will complete medical/scientific writing assignments, as required for clinical projects undertaken by the Company, take a leading role in preparing assigned documents, which includes but is not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews and communicating directly with the client on medical writing-related issues as they arise, as well as coordinate information and data inputs from team members when preparing trial documents. Independently plan and organize workload for assigned projects and tasks, identify project needs, track timelines, and implement customer requests. The Medical Writing Manager will also be required to support the Global Head or Designee with the management, coordination, oversight, and functioning of the Medical Writing Department.


Essential Functions:

Write, or coordinate the writing of appropriate sections of:

  • Protocols and protocol amendments.
  • Clinical study reports, addenda, and synopses.
  • Collation of finalized clinical study reports.
  • Investigator’s Brochures.
  • Safety update reports.
  • Publications.
  • Statistical reports (provide assistance to the biostatistician).
  • Submission documents.
  • Document formatting and editing, where required.
  • Oversee and/or allocate resources (including contract staff and Vendors) for the provision of medical writing services as and when required for clinical or other projects awarded to the Company.
  • With some assistance from Senior Management, support other groups within the Company to meet goals, develop new business, and promote existing business.
  • Other documents in accordance with a contractual requirement.


Administrative and Line Management (if applicable):

Meeting and/or communicating regularly with other Global Head or Designee for:

  • General updates on the Department’s activities.
  • Planning resources for awarded potential and re-allocated projects.
  • Ensuring that adequate, appropriately trained personnel resources are available to perform contracted projects to the highest possible standard.
  • Support the Global Head or Designee to facilitating training and personal development of Medical Writing staff.
  • Support the Global Head or Designee with recruiting and selecting new personnel for positions approved by Executive Management, in accordance with the growth and planned development of the department.
  • Conducting regular performance appraisals of direct reports, including gathering feedback from other functional managers.
  • Approving leave of direct reports (e.g., annual, sick, study, compassionate, maternity leave) in consultation with the Directors, as relevant. Functional (according to relevant guidelines, laws, and procedural documents).


Knowledge, Skills, and Abilities:

  • Expert medical/scientific writing skills.
  • Uncompromising attention to detail and the ability to think analytically.
  • Able to communicate in English, effectively and accurately, both orally and in writing.
  • Effective time management skills.
  • Ability to prioritize workload.
  • Excellent interpersonal skills and problem-solving ability.
  • Diplomatic conflict management.
  • Effective organizational and negotiation skills.
  • Strong computer skills, with the ability to learn appropriate software, as necessary.
  • Proficient knowledge of human physiology.
  • Basic knowledge of pharmacology areas.
  • Proficient knowledge of therapeutic areas.
  • Proficient knowledge of all relevant Company SOPs, ICH GCP and local legal requirements, European, FDA and other relevant international guidelines applicable to clinical research.


Position Requirements:

Education: Bachelor’s or higher graduate degree (or its international equivalent) in a medically related scientific field.

Preferred Job-related Experience: A minimum of 7 (seven) years of demonstrated medical scientific/medical writing experience. Adequate experience in clinical research. Experience in third-party service provider selection, contracting and management. Experience in managing budgets and familiarization with financial forecasting and cost accrual processes. Successful experience of operating in a resource-constrained work environment. Global project management experience preferred.


Physical Expectations:

  • Typical office environment.
  • Ability to sit or stand for extended periods of time.
  • Ability to move 5-15 lbs.; or 2.26 - 6.8 kg.


Travel Requirements:

Expected travel time is less than 10% for this position.


This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.


FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.